euromeeting advance programme • neutral, global forum for more than 3,000 professionals involved...

EuroMEEting

AdvanceProgramme

• Neutral, global forum for more than 3,000 professionals involved in the development of medicines from over 50 countries

• Speakers from the European Medicines Agency, the European Commission, the FDA and other regulatory agencies from European countries and other regions of the world

• More than 200 exhibitors on one of the largest exhibition floors in Europe

• Unparalleled multidisciplinary networking opportunities

• Student and professional poster sessions

• Active involvement of patient organisations

• Pre-conference tutorials led by expert instructors

• Hot topic sessions

gEnEva 2011

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28-30 March 2011PalexpoGeneva, Switzerland

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Table of Contents

Programme Advisors

Christer Backman, EU Coordinator Scientific and Regulatory Strategy, Medical Products Agency, Sweden

Melek Bostanci Onol, DRA Manager, Boehringer Ingelheim Ilac Ticaret A.S., Turkey

Laurie Burke, Director, Study Endpoints and Labeling, Office of New Drugs, CDER, FDA, USA

Stephane Callewaert, Senior Manager, Regulatory Policy, Worldwide Vaccine Registration, GlaxoSmithKline Biologicals, Belgium

Daan Crommelin, Scientific Director, Top Institute Pharma, The Netherlands

Fritz Erni, Consultant, Switzerland

Michael Drummond, Professor of Health Economics, University of York, UK

Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU

Bruno Flamion, Chair Scientific Advice Working Party (SAWP), CHMP; Professor Clinical Pharmacology, University of Namur, Belgium

Aiden Flynn, Director, Biomarkers and Analytics, GlaxoSmithKline, UK

Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, Pfizer AB, Sweden

David Haerry, EATG Representative, European AIDS Treatment Group, Belgium

Katarina Halling, Senior Scientist, PRO Consulting, Sweden

Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The Netherlands

Bengt Jönsson, Associate Professor, Stockholm School of Economics, Sweden

Susanne Keitel, Director, EDQM (European Directorate for the Quality of Medicines and Healthcare), EU

Armin Koch, Head of Institute of Biometry, Hannover Medical School, Germany

Suzette Kox, Senior Director, Scientific Affairs, EGA, Belgium

Amanda Maxwell, Manager, SFL Regulatory Affairs Consulting, UK

Clare McGrath, Senior Director HTA Policy Europe/ROWD, Pfizer Ltd., UK

Estelle Michael, Senior Manager, Regulatory Policy, GlaxoSmithKline

Biologicals, Belgium

Marisa Papaluca-Amati, Head of Scientific Support and Projects, European Medicines Agency, EU

Mira Pavlovic, Deputy Director, DEMESP, HAS Haute Autorité de Santé, France

Munir Pirmohamed, NHS Chair of Pharmacogenetics, The University of Liverpool, UK

Andrea Rappagliosi, Vice President European Government Affairs & Head of Brussels Office, GlaxoSmithKline, UK

Ingela Wiklund, Senior Research Leader, United Biosource Corporation, UK

John Wise, Executive Director, The Pistoia Alliance, UK

Programme Advisors 2

EuroMeeting 2011 Co-Chairs' message 3

EuroMeeting 2011 Theme Leaders 4

Plan your EuroMeeting Experience 5

Opening Plenary 6

Special Sessions 7-8

Student and Professional Posters 8-9

DIA Fellowships 10

Pre-Conference Tutorials 10-15

Greening the EuroMeeting 16

Sessions: Theme 1 - 15 17-45

Hot Topics and Stand Alone Sessions 45-48

New at the EuroMeeting 48

Exhibitors 49

About Geneva 50

Networking Events 51

Accommodation and Transport 52

EuroMeeting at a Glance 55-57

Key Contacts 58

Registration Form 59

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Dear Colleague,

The landscape of drug development is changing. At the DIA’s 23rd Annual EuroMeeting in Geneva, taking place from 28-30 March 2011, we are introducing important new themes such as Global Drug Development in the Real World. These will highlight new perspectives on current systems and stimulate discussion on new ways of working and opportunities for new partnerships. Discovering new synergies will be an important focus and will be particularly appropriate in the truly international setting of Geneva.

Innovation is always centre stage at the DIA – this EuroMeeting will ask whether we are really delivering the benefits of new science and technology. Are the products of pharmacogenomics coming on stream? Is patient safety improving as a result of pharmacogenetic knowledge and will the drug-device boundary disappear? Hand-in-hand with this debate will be a discussion on better and early access to innovative treatments. Risk management throughout the product lifecycle is now embedded in practice both in industry and the regulatory world. Is it time to move on to benefit/risk management in practice and to align regulatory process and health technology assessment?

By 2011, regulation will have reached another significant milestone with the package of measures on pharmacovigilance and counterfeit medicines. The challenges will be in implementing these new measures to achieve the aimed-for benefits in public health protection without compromising the better regulation principles of proportionality and targeting.

Better risk communication remains perhaps the biggest challenge of all. No medicine or healthcare product is completely risk-free. Tools and methodologies for detecting and managing risk have advanced significantly but arguably industry and regulators have yet to benefit from the science of risk communication. Can we embrace the best practices from other fields and disciplines?

With so many new topics to debate, you may ask what will you not see on the Geneva EuroMeeting 2011 scientific programme! At this meeting the patient perspective will no longer be addressed in a separate theme. This does not mean that the patient perspective is being ignored. On the contrary, it will be evident in every theme and throughout the whole meeting. We feel strongly that patients’ contributions should no longer be an add-on or an after-thought but integrated in every aspect.

We wish to ensure that the DIA’s 23rd Annual EuroMeeting in Geneva will be a milestone in drug development science, regulatory evolution, stakeholder involvement and partnership working. Join us there, contribute your views and participate in debate – we will all benefit.

June Raine and Valdo Arnera

Valdo ArneraGeneral Manager, PHT Corporation, Switzerland

A medical doctor by training, Dr. Valdo Arnera has over 25 years of experience in the pharmaceutical industry. After having practiced

medicine in various positions, he started his career in the industry as a clinical pharmacologist in a Ciba-Geigy subsidiary. In 1992, he

founded the first European Central Clinical Laboratory dedicated to clinical trials, SciCor (now Covance Central Laboratory). He joined PHT,

an electronic diary technology provider in 2000, and founded its European affiliate in Geneva in January 2001. Skilled in both science and

management, Dr. Arnera currently serves as the General Manager of PHT’s European operations. He has also been an active Co-chair of the

DIA’s Special Interest Area Communities (SIAC) eClinical and Standards and previously served on the Advisory Council of Europe for several

years.

June RaineDirector, Division of Vigilance Risk Management of Medicines, MHRA, UK

Dr. June Raine trained in general medicine in Oxford after completing a Master's degree by research in Pharmacology. Her interest in drug

safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development

within the UK national authority. Appointed in 1999 to head Pharmacovigilance in the Medicines Control Agency (now Medicines and

Healthcare products Regulatory Agency), she was elected in 2005 to chair the CHMP’s Pharmacovigilance Working Party. She is also

a member of the WHO Advisory Committee on Safety of Medicinal Products. Her special interests are in monitoring the outcomes of

regulatory action, risk communication and patient involvement in the regulatory process.

EUROMEETING 2011 CO-CHAIRS’ MESSAGE

Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they represent, or that of the DIA.

Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media is prohibited without prior written consent from DIA.

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Christelle Anquez-TraxlerRegulatory and Scientific Affairs Manager, AESGP, Belgium

Timothy BuxtonHead of Sector, ICT Development, European Medicines Agency, EU

Vincenzo CannizzaroHead of Regulatory Affairs, Qualitec Pharma, Spain

Chris ChamberlainMedical Director, Personalised Medicines, AstraZeneca Pharmaceuticals LP, UK

Olivier ChassanyMedical Head, Clinical Research & Development Department, Assistance Publique - Hôpitaux de Paris, France

Nancy ClaudeDirector of Drug Safety, IRIS, France

Philippe CloseChief Safety Officer, Novartis Pharma AG, Switzerland

Bruno FlamionChair Scientific Advice Working Party (SAWP), CHMP; Professor Clinical Pharmacology, University of Namur, Belgium

Georges FranceVice President, Quality Strategy, Global Quality Operation, Pfizer, UK

Shayesteh Fuerst-LadaniDirector, SFL Regulatory Affairs and Scientific Communication, Switzerland

Robert HemmingsStatistics Unit Manager, MHRA, UK

Michael HotzeDirector, Head of Clinical Research, Institut Straumann AG, Switzerland

Wills Hughes-WilsonSenior Director, Health Policy Europe, Genzyme, Belgium

David Iberson-HurstVice President, Technical Strategy, CDISC, UK

Angelika JoosDirector, Regulatory Policy, Europe, Merck Sharp & Dohme (Europe) Inc., Belgium

Jürgen KüblerGlobal Head, Statistical Safety Sciences, Novartis Pharma AG, Switzerland

Pierre-Yves LasticSenior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France

Birka LehmannDirector and Professor, Head of Licensing Division 3, BfArM, Germany

Andrew P. MarrDirector, Global eRegulatory Development, Global Regulatory Operations, GlaxoSmithKline, UK

Henrik Kim NielsenCorporate Vice President, Novo Nordisk A/S, Denmark

Michael PfleidererHead of Section, Viral Vaccines, Paul-Erhlich-Institut (PEI), Germany

Ineke RijnhoutConsultant, Kenko International, The Netherlands

Jean-Louis RobertHead, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg

Tomas SalmonsonVice Chairman, CHMP, Director Scientific and Regulatory Strategies, MPA, Sweden

Urszula Scieszko-FicRegistration Director, Temapharm Sp. z.o.o., Poland

Philippa Smit-MarshallVice President Medical and Scientific Affairs, PharmaNet B.V., The Netherlands

Per SpindlerDirector, Biopeople, University of Copenhagen, Denmark

Sabine StrausHead of Pharmacovigilance, Medicines Evaluation Board (MEB), The Netherlands

Thomas VerstraetenHead Biologicals Clinical Safety & Pharmacovigilance, GlaxoSmithKline Biologicals, Belgium

Christa Wirthumer-HocheDeputy Head, AGES PharmMed, Austria

About the DIA EuroMeetingThe Drug Information Association’s Annual EuroMeeting is global in scope, attracting well over 3,000 professionals from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, academic research centres, regulatory agencies and health ministries as well as delegates from patient organisations. This convergence affords participants the opportunity to network with professional colleagues from around the world.

The DIA is a professional association of approximately 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products. The DIA is committed to the broad dissemination of information on the development of new medicines or generics, biosimilars, medical devices and combination products with continuously improved professional practice as the goal. The DIA is an independent non-profit organisation. The voluntary efforts of DIA members and speakers allow the DIA to organise conferences, workshops and training courses and provide publications at a reasonable, competitive cost.

DIA Europe's Customer Services Team will be pleased to assist you with your registration. Please call us on +41 61 225 51 51 from Monday to Friday between 08:00 and 17:00 CET.

EUROMEETING 2011 THEME LEADERS

5PLAN YOUR EUROMEETING EXPERIENCE

17:30-18:00 Student Poster Awards Ceremony at the DIA booth

17:30-18:30 The Tuesday Reception on the Exhibition Floor

18:30-20:00 Joint Swissmedic and WHO Satellite Session – See page 7

Wednesday, 30 March 201107:30-17:30 Conference Registration/Information Open

08:00-16:00 Exhibition Open

08:00-09:00 Welcome Coffee

09:00-10:30 Session 5 - Choose from 15 parallel sessions!

10:30-11:00 Coffee Break


11:00-12:30 Town Hall Meeting - See page 7-8

13:00-13:30 Professional Poster Awards Ceremony at the DIA booth

12:30-14:00 Lunch




CONFERENCE CLOSES

Sunday, 27 March 201115:00-18:00 Conference Registration/Information Open at Palexpo.

Avoid the rush on Monday by picking up your badge on

Sunday afternoon.

17:00-17:30 Student Welcome: Students only

17:30-18:00 Patient Fellowship and Patient Speakers Welcome: Patient representatives only

Monday, 28 March 201107:30-19:00 Conference Registration/Information Open

09:00-12:30 Pre-Conference Tutorials – See page 9-14

09:00-10:30 Student Workshops - see page 7

11:00-12:30 Student Session – See page 7-8

11:00-12:30 Young Professionals Session – See page 7

CONFERENCE OPENS

12:30-14:00 Student and Young Professional Networking Lunch

12:30-14:00 Lunch


14:00-17:15 Opening Plenary Session – See page 6

17:30-19:30 La Grande Reception:

Networking Reception at the Ramada Park Hotel

Tuesday, 29 March 201107:30-18:30 Conference Registration/Information Open

08:00-09:00 Welcome Coffee





12:45-13:45 Patients’ Working Lunch

12:30-14:00 Lunch

12:30-13:15 DIA Special Interest Area Communities (SIACs) –

Meet and Eat

13:30-14:00 Speed Networking




16:00-17:30 Japanese Regulatory Session – See page 7

► Knowledge ► Networking ► EuroMeeting Information

Special Session | GCP Forum

Session 1605/1606 | Wednesday, 30 March 2010 | 09:00-12:30 THE CHALLENGES FOR REGULATORS AND SPONSORS WHEN DEALING WITH CLINICAL TRIALS IN A GLOBAL SETTINGSession Co-Chairs: Gabriele Schwarz, Head, GCP Inspection Services, BfArM, GermanyBeat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, Switzerland

FDA's International Collaborative Activities to Exchange Scientific, Regulatory and Ethical Information in the Conduct of Clinical TrialsCynthia Kleppinger, Medical Officer, Division of Scientific Investigations, Office of Compliance, CDER FDA, USA

International Cooperation on GCP and Ethical rRquirements for Clinical Trials - Current EMA activitiesFergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU

International Clinical Trials – Current Afssaps activitiesPierre-Henri Bertoye, Inspectorate and Companies Associate Director, Afssaps, France

Risk-Based Quality Management in Clinical Trials- A European Regulator’s View Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany

Industry / CRO delegates invited

See page 43 for details.

6 OPENING PLENARY

O P E N I N G P L E N A R YGENEVA 2011

Monday, 28 March 2011 | 14:00 - 17:15

The 23rd Annual DIA EuroMeeting 2011 opens at a time of unprecedented change and challenge for the pharmaceutical industry, academia and regulators – in a climate of great expectations for groundbreaking scientific innovation, efficient cost-effective delivery, high standards of patient protection, excellent communication and transparency and best value for payers as well as patients and professionals. In the international city of Geneva it is right that we should be thinking beyond the boundaries of Europe. We should be building bridges, removing old boundaries: there is no doubt that the time has truly come for all stakeholders to work together in the best interests of public health. It is time for clearly defined goals, commonality of purpose and above all for visionary leadership. Where should our priorities be, and how can these enormous challenges become opportunities? It is therefore fitting that the EuroMeeting 2011 should begin with a Keynote Address from Commissioner John Dalli of DG SANCO. Commissioner Dalli will share his vision for optimising the health of the 500 million citizens of Europe and the part to be played by pharmaceuticals in achieving this. Following the move of the responsibility for pharmaceuticals from DG Enterprise to DG SANCO it is a unique opportunity to look ahead. This vision will be a framework for the themes and sessions of the Euromeeting to follow, and a context for the detailed discussions over the following days. In these exciting times, discussion must be challenging as well as reflective, stimulating and informative. So what better time than now to get down to reality, and listen to leaders in their fields debate. Come and join us in the plenary, participate in the debate and cast your vote!

Oxford Debate

There will also be an “Oxford Debate” following the University of Oxford’s eminent tradition. The working title for the debate is: "The current regulatory system does not support timely patient access to beneficial medicines".

ModeratorHans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU

DebatersAndrew Dillon, Chief Executive, NICE, UKPeter Bonne Eriksen, Senior Vice President, Global Regulatory Affairs, Novo Nordisk, DenmarkGreetje Goossens, Counseler, European Myeloma Platform, The Netherlands

Keynote Address

John DalliEuropean Commissioner responsible for Health and Consumer Policy

John Dalli started to serve as a Cabinet Minister in the Maltese Government

in 1987 having been first elected to the House of Representatives of Malta on

behalf of the Nationalist Party in 1987. He served as Parliamentary Secretary

for Industry (1987-1990), Minister of Economic Affairs (1990-92), Minister of

Finance (1992-1996, 1998-2003), Minister of Finance and Economic Affairs and

Minister of Foreign Affairs and Investment Promotion (2004). Between March

2008 and February 2010, John Dalli served as Minister for Social Policy which

includes the health, housing, employment and industrial relations portfolio.

As a qualified accountant, Dalli also worked in the private sector in Malta and

abroad, both in industry and as an independent consultant.

In February 2010 John Dalli was appointed European Commissioner responsible

for Health and Consumer Policy.

7This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.

SPECIAL SESSIONS

Student SessionsMonday, 28 March 2011 | 09:00-09:40PRESENT WITH CONFIDENCE WORKSHOPInstructor: Judy Churchill, Communication Skills Specialist, France

There are three small things that can make a BIG difference to your presentation, increase your confidence and impact your audience:

• The Hook: –how to hook in your audience from the start – the all important first minute.• Voice: – how to use tone, intonation, and speed of delivery for maximum impact.• Body Language: - your body speaks louder than your words – how to use it to get the effect you want.

Monday, 28 March 2011 | 09:50-10:30CURRICULUM VITAE WORKSHOPInstructor: Martin Zuber, HR Senior Manager, Baxter BioScience, SwitzerlandStudents attending this workshop will receive tips and advice on creating a winning CV.

Monday, 28 March 2011 | 11:00-12:30DIA STUDENT CHAPTER SESSIONFacilitator: Judy Churchill, Communication Skills Specialist, France and UK

In partnership with the European Pharmaceutical Students’ Association (EPSA) and the International Federation of Medical Students’ Associations (IFMSA).

Co-ChairsJoao Eduardo Duarte, Representative Lisbon Student Chapter, PortugalSanziana Marcu-Lapadat, VP of External Affairs, EPSA, BelgiumDespina Polidou, IFMSA Regional Coordinator for Europe, GreeceSara Popik, Representative Danish Student Chapter, Denmark

All student participants are invited to join an informal networking and information session in which they can learn more about a range of professional disciplines in the pharmaceutical world: What do they involve? What is the best way in? What are the challenges and the opportunities?

A group of experienced professionals from a range of pharmaceutical backgrounds will lead small groups of students in discussion around the room. There will be an open format and students will move from one group to another.

Young Professionals SessionTips and Tricks for your Personal DevelopmentMonday, 28 March 2011 | 11:00-12:30Session Chair: Estelle Michael, Senior Manager Regulatory Policy and Intelligence, GlaxoSmithKline, Biologicals, Belgium

Facilitator for the WorkshopAnne Corvoisier, Managing Editor, Regulatory Intelligence Healthcare and Science, Thomson Reuters, France

In this session we aim to provide some enlightenment and hopefully some fun!The session will start with reflections on the toils of being a Young Professional, along with some advice on how Professionals can develop and progress in their Careers. There will then be a “how to” demonstration of one of the Key Skills for development and progression:Negotiation. This will be followed by a group discussion.

Introduction “Experience is not lost on the young”Reflections and thoughts to introduce the session.Estelle Michael, Senior Manager Regulatory Policy and Intelligence, GlaxoSmithKline, Biologicals, BelgiumMini Workshop on Negotiation SkillsEstelle Michael, Anne Corvoisier

Wrap UpEstelle Michael

Heads of Medicines Agencies SessionSession 1602 | Tuesday, 29 March 2011 | 11:00-12:30Session Chair: Kent Woods, Chief Executive, MHRA, UK

This session describes the five year strategy of the Heads of Medicines Agencies group, published in November 2010. Individual presentations will consider the main priorities of the strategy and how it is intended that they should be achieved. They will be followed by a panel discussion.

Chairman's Introduction and Overview Kent Woods, Chief executive officer, MHRA, UK Supporting Public Health by the Continuing Improvement of Pharmacovigilance in the EUJytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark

Supporting Industry by Operating Efficient and Accessible MRP/DCPAginus Kalis, Executive Director, Medicines Evaluation Board (MEB), The Netherlands Making Full Use of IT for the Work of the European Medicines Regulatory NetworkMarcus Muellner, Director, AGES PharmMed, Austria

Patient Representatives & Patient Speakers Working Lunch

TUESDAY 29 MARCH 2011 | 12:45-13:45Patient Representatives Working Lunch – Patients Representatives OnlyFacilitator: Mary Baker, MBE, President of European Federation of Neurological Associations (EFNA), UK. President of European Brain Council, EU

Mary Baker will lead a discussion on the challenging times in Europe for Patient Groups and how by working together, sharing experiences, Patient Representatives can help one another manage these challenges and improve the quality of life for those whom they represent. Mary looks forward to meeting and discussing the issues at hand in an informal environment.


SPECIAL SESSIONS | PROFESSIONAL POSTERS

2015 Roadmap SessionSession 1603 | Tuesday, 29 March 2011 | 14:00-15:30Session Chair: Noel Wathion, Head of Public Health Protection, European Medicines Agency, EU

On 26 January 2010, the European Medicines Agency published a draft paper setting out its vision for the strategic development of the Agency for the five years to 2015. Building on the progress of its previous five-year strategy, the Road Map to 2015 charts the way forward for the Agency amid rapid developments in medical science and pharmaceutical research, as well as the continuing evolution of the European and international regulatory environments. With this strategy paper to guide it, the Agency will seek to consolidate its achievements to date and further strengthen its role as a guardian of human and animal health in the European Union.

EMA's Roadmap to 2015 - the final versionNoel Wathion, Head of Patient Health Protection, European Medicines Agency, EU

From Vision to Reality: Key issues and challenges Emer Cooke, International Liaison Officer, European Medicines Agency, EU

Town Hall MeetingSession 0206 | Wednesday, 30 March 2011 | 11:00-12:30MEET THE REGULATORSModerator: Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria

The Town Hall Meeting is an open interactive session where participants can ask key decision makers in the European Regulatory system burning questions. The panel will include representatives from the European Medicines Agency, National Competent Authorities and a patient organisation.

The topics/questions discussed are decided by the attendees and should be related to:• Responsibility of the Agencies in the EU network• Authorisation and Maintenance of Medicinal Products; Benefit/Risk Methodologies• Pharmacovigilance• International Cooperation and Inspection-Related Issues• Electronic Submission• The Role of Patient Organisations

Responsibilities of the Agencies in the EU NetworkNoel Wathion, Head of Public Health Protection, European Medicines Agency, EU

Aginus Kalis, Chair HMA-MG, Executive Director, Medicines Evaluation Board (MEB), The Netherlands

Authorisation and Maintenance of Medicinal Products; Benefit/Risk MethodologiesHans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU

Eric Abadie, Chair CHMP, Chair Pharmacogenomics Working Party, General Director, Afssaps, France

Truus Janse-de Hoog , Chair CMD(h), Staff member MEB, European cluster, Medicines Evaluation Board, The Netherlands

PharmacovigilanceJune Raine, Director, Chair PhVWP, Director, Division of Vigilance Risk Management of Medicines, MHRA, UK Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU

International Cooperation and Inspection-Related IssuesEmer Cooke, International Liaison Officer, European Medicines Agency, EU

Electronic SubmissionTimothy Buxton, Head of Sector, ICT Development, European Medicines Agency, EU The Role of Patient OrganisationsAlbert Van der Zeijden, Board Member, International Alliance of Patients Organisations, UK

Joint Swissmedic and WHO Satellite SessionSession 1900 | Tuesday, 29 March 2011 | 18:00-19:30SWISS SATELLITE SESSION: COOPERATION BETWEEN SWISSMEDIC AND WHO Session Co-Chairs:Petra Doerr, Head of Management Services & Networking, Swissmedic, Switzerland

Lembit Rägo, Coordinator, Quality Assurance and Safety: Medicines, Essential Medicines and Pharmaceutical Polices, WHO, Switzerland

Establishing and maintaining a well-functioning network between international organisations like the WHO and Regulatory Authorities is key to address public health issues in a globalised world. This session will elaborate on the potential impact of cooperation between WHO and regulators to the industry. It will also look at how WHO works with regulators in general and in particular with the Swiss Agency for Therapeutic Products, Swissmedic. Finally, we will look at how the cooperation works, what challenges had to be addressed and what the outcome finally was by presenting two practical examples taken from the field of pharmacovigilance and counterfeit drugs.

Introduction: How the WHO works with regulators Lembit Rägo, Coordinator, Quality Assurance and Safety: Medicines, Essential Medicines and Pharmaceutical Polices, WHO, Switzerland

Overview of Cooperation between Swissmedic and the WHO Cordula Landgraf, Head of Networking, Swissmedic, Switzerland

Real-time Pharmacovigilance: The development of Paniflow Pia Caduff-Janosa, Head Unit Vigilance, Swissmedic, SwitzerlandRudolf Stoller, Head of Division Safety Medicines, Swissmedic, Switzerland

Counterfeit Drugs: The way forward Karoline Mathys Badertscher, Head of Sector Market Surveillance, Swissmedic, Switzerland


STUDENT POSTERS | EXHIBITION

Call for Student Poster Abstracts

Deadline: 1 December 2010Full-time university students, residents and fellows are invited to submit abstracts for the Student Poster Session which will take place on Tuesday, 29 March 2011 at the EuroMeeting in Geneva.

Prizes will be awarded to student winners based on the following criteria:• Bona fide research project• Specific objectives and hypothesis• Clear methods• Analysis of actual data and results• Conclusion

A maximum of 20 abstracts will be selected for the student poster presentation.

Eligibility:Full-time students, residents or fellows at the time of the EuroMeeting 2011. One author must attend the EuroMeeting. Past DIA EuroMeeting or Annual US meeting Student Poster Presenters will not be eligible.

Benefits for Accepted Abstracts:• One fully supported registration for the EuroMeeting to include: return

flight to Geneva, three nights' hotel accommodation and complimentary registration for the EuroMeeting

• Abstracts will be published in an early 2011 issue of the Drug Information Journal

• Prizes for three winning posters

Abstract Guidelines:• All poster abstracts must be received by Wednesday, 1 December 2010.

Submit your abstract online by going to www.diahome.org and clicking on the EuroMeeting icon.

• Abstracts are limited to 100 words• A student may submit only one abstract• Abstracts may not refer to specific brand names• Abstracts should follow a structured format including objectives, methods,

results and conclusions• Submissions must include complete contact information• Abstracts will be reviewed and authors notified of results by Wednesday, 15

December 2010

If you require further information on Student or Professional Posters please contact Maureen McGahan at DIA Europe: [email protected]

To submit a poster, please visit www.diaeurope.org/euromeeting2011

Call for Professional Poster Abstracts

Deadline: 14 January 2011A maximum of 40 abstracts from full-time professionals will be selected for the professional poster presentation to be held on Wednesday, 30 March 2011.

Selected professional poster presenters will be required to pay the applicable meeting registration fee and will be responsible for all other meeting expenses.One professional poster will be selected at the EuroMeeting 2011 Geneva as the winner of the EuroMeeting 2011 Professional Poster Award.

Abstract Guidelines:• All professional poster abstracts must be received by Friday, 14 January 2011.

Submit your abstract online by going to www.diahome.org and clicking on the EuroMeeting icon

• Abstracts are limited to 100 words • Abstracts may not refer to specific brand names• Abstracts should follow a structured format including objectives, methods,

results, and conclusions• Submissions must include complete contact information

If you require further information on Student or Professional Posters please contact Maureen McGahan at DIA Europe: [email protected]

Reach your ideal target audience at the EuroMeeting 2011Showcase your company’s product or service to over 3,000 drug development professionals from over 50 countries at the EuroMeeting 2011 in Geneva.

Join over 200 exhibitors to interact with professionals from the pharmaceutical and device industry, from academia and healthcare, regulatory agencies and patient organisations.

Booth space is sold on a first come first served basis. The fee is € 4,550 plus 7.6% Swiss VAT (from 1 January 2011, VAT will be charged at 8%) for a 3x3m space. Each booth space includes pre-fitted shell-scheme, standard electrical supply, one table, three chairs, coffee breaks, lunches and receptions, one full meeting registration (which allows access to all scientific sessions) and up to three exhibit booth personnel registrations.

Sign up now to be sure of the space of your choice. Download the application form today at www.diahome.org/euromeeting2011 > Click on the EuroMeeting icon > Exhibition

For more information on exhibition space and facilities, please contact Natacha Scholl at DIA Europe on +41 61 225 51 59 or email: [email protected]


DIA FELLOWSHIPS

CLINICAL RESEARCH – A CAREER OPPORTUNITY FOR STUDENTS IN LIFE SCIENCE DISCIPLINES Session Chair:Ingrid Klingmann, Managing Director, Pharmaplex bvba, Belgium

The clinical part of drug development is highly complex from a scientific, ethical, regulatory, methodological and organisational point of view. The quality of the medicinal products and the reliability of results generated from data in clinical trials need to be assured to provide patients the best possible treatment options. This complex process requires professional planning and performance as well as seamless collaboration from many different stakeholders which provides job opportunities for people with very different educational backgrounds, experience and skills.In this training programme students will receive an overview of the clinical development process and the involved disciplines and will be provided with the opportunity to discuss possible career paths. This will help participants identify areas of interest and how to best utilise their skills in this very fast moving, international, scientifically and ethically highly relevant professional environment.

Session 1 11.30-13.00

Introduction into overall clinical trial situation (what are clinical trials, principle elements, important terms) & Role of the pharmacist in study medication handling GCP, GMP: link between: GCP for study medication – at clinical trial and investigator site

Lunch

Session 2 13.30-15.00

Role for Life Science Professionals in Clinical Trials Management and Quality Assurance aspect Clinical trials, Clinical Trials Supervision, Management and Quality Assurance & Q&A

Student Pre-Conference Tutorials | Sunday, 27 March 2011 | 11:30 - 15:30

Tutorial 01 - Roundtable Discussion (Special €150 + VAT rate)

GCP INSPECTION AND AUDIT FINDINGS

Beat Widler, Global Head of Clinical Quality Assurance, F. Hoffmann-La Roche Ltd., SwitzerlandFergus Sweeney, Head of Sector, Inspections, European Medicines Agency, EU

During the course of GCP inspections some important themes are identified by the inspectors as being common to multiple inspections. In a similar way GCP auditors working for industry identify key issues of concern. This roundtable provides an opportunity to identify and discuss some of these key findings with a panel of GCP inspection experts from regulatory authorities and GCP audit experts from industry/academia. The topics selected for discussion will be chosen, by the panel, from responses to a short questionnaire circulated to registered participants prior to the EuroMeeting.

Discussion ObjectivesThe purpose of this roundtable is to provide an opportunity for open, timely discussion of key GCP issues arising from inspection and from audits:• Establish a common understanding of inspection and audit findings and their

basis in regulation, guidance and quality principles• Build consensus on the priority issues for resolution• Better evaluate audit and inspection findings and their impact on GCP

compliance and the ethical and scientific validity of clinical trials • Update on new issues/initiatives of regulators and of auditors

Target Audience• GCP compliance auditors and management and staff with GCP related QC

responsibilities from both industry and academia • Clinical research management and project leaders from both industry and

academia • GCP inspectors

Tutorial 02

THE ‘NEW’ VARIATION REGULATION IN PRACTICE – ADVANTAGES AND PITFALLS

Susanne Winterscheid, Head of Project Management of Licensing Division 4, BfArM, Germany

The ‘new’ EU variation regulation (Commission Regulation (EC) 1234/2008) applicable since 1 January 2010 is aimed on one hand to simplify the submission of variations and on the other hand to give more strategic options to the applicant. Has this goal already been achieved? As usual, the practical implication of legislation has raised on both sides – the industry and the competent agencies. a number of questions. After one year of practical experience with the variation regulation a first resumé concerning the real advantages and so far identified pitfalls has been given. This takes into account the provided Best Practice Guides and Q&A documents and the practical experience gained thus far.

The aim of this tutorial is to identify challenges and how they are solved by common and agreed solutions and interpretations. The area covered will concentrate on the new elements of the variation legislation (e.g. grouping) including annual report, work sharing and experiences with classification of change (Article 5, upgrading during validation), implementation, etc.

Pre-Conference Tutorials | Monday, 28 March 2011 | 09:00 - 12:30


Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Identify the crucial definitions and interpretations of the Variation Guidelines

and Best Practice Guides and to recognise their practical relevance• Identify advantages and avoid pitfalls in the regulatory framework• Identify safe resources with strategic decisions Target AudienceRegulatory affairs professionals from industry involved in the compilation, organisation and management of variations in the decentralised (MRP/DCP) or centralised procedure.

Tutorial 03

ORPHAN DRUGS IN THE EU: FROM DESIGNATION TO MARKETING AUTHORISATION

Katrin Rupalla, Associate Director, Regulatory Affairs Europe, Celgene International SARL, SwitzerlandJordi Llinares, Head of Orphan Medicines, European Medicines Agency, EU

In this tutorial you will hear about the orphan drug legal framework in general and what are the latest updates. In addition, the tutorial is meant to provide an overview of the orphan drug application process from designation to approval of marketing authorisation and its practical implications based on recent examples. This also includes in-depth review and analyses of topics such as orphan market exclusivity, similarity and significant benefit. Speakers will include experts from the European authorities, but you will also hear from industry representatives about the strategic aspects, experiences and learnings with regard to regulatory framework for orphan drugs in the EU.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Apply the information they have obtained on procedures and requirements

for an orphan drug application in the EU and US• Identify and respond to potential issues that may arise during an orphan

designation procedure

Target AudienceThis tutorial will be of interest to all those who would like to hear about the latest update of the orphan drug legal framework in the EU and most recent experience with regard to practical implications. This will in general be professionals from Drug Regulatory Affairs, Clinical Science and Public Affairs.

Tutorial 04

DEVELOPMENT OF PAEDIATRIC MEDICINAL PRODUCTS FROM A REGULATORY POINT OF VIEW

Thomas Dobmeyer, Managing Director, YES Pharmaceutical Development Services GmbH, GermanyAnne Isabel Roth, Clinical Assessor, BfArM, Germany

Following an introduction to the medical, legal and regulatory background of the development of medicinal products for paediatric use, representative case studies of paediatric investigation plans will be presented. Participants will then learn to apply their knowledge. In small groups they will prepare an outline of the clinical part of a fictitious PIP for a medicinal product with a well known active substance which should be further developed for use in paediatric patients.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Define the legal and regulatory requirements for the development of

medicinal products for paediatric use in the EU• Explain the content of Paediatric Investigation Plans (PIPs) as well as the

processes required to prepare, submit and implement PIPs• Apply knowledge to briefly outline the clinical part of a PIP for a well known

active substance

Target Audience• This tutorial is designed for people working in regulatory affairs who wish to

have a more in-depth understanding of paediatric medicinal products.

Tutorial 05

AFTER THE PIP DECISION: MODIFICATION OF THE AGREED PIP, VALIDATION AND COMPLIANCE CHECK

Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, EUMette Due Theilade Thomsen, Department Manager, Novo-Nordisk, Denmark

This tutorial, also presented in 2010, is aimed at illustrating the steps that follow the EMEA decision on an agreed PIP (or on a waiver), including the request for modification of an agreed PIP, applications for a new PIP (for the same product), and the procedures at the time of validation/compliance check.

Learning ObjectivesAt the conclusion of this tutorial, attendees will be able to:• Assess the need to request a modification of an agreed PIP• Plan the timing of the request for compliance check• Decide when separate PIPs are more convenient than a single PIP• Identify the steps in the validation-compliance check procedure

Target AudienceRegulatory affairs specialists, SMEs, project managers

Tutorial 06

SUCCESSFUL OUTSOURCING OF NON-CLINICAL DEVELOPMENT PROGRAMMES – EXPERIENCES, RECOMMENDATIONS, VALUABLE TIPS

Rüdiger Häcker, Global Business Development, Medicons GmbH, SwitzerlandKai Blumbach, Manager, Safety Assessment Toxicology, Harlan Laboratories Ltd., Switzerland

This tutorial will summarise the experiences of a contract research organisation which offers services for the conduct of non-clinical development programmes and the corresponding experiences from the view of a consultant which is managing the outsourcing for companies. It will illustrate how to manage the inherent key conflict of interest: The client is interested in getting better service in less time at lower costs whereas the CRO is interested in generating revenues - at a sufficiently high level of quality and satisfaction for the clients and the regulatory authorities.

TUTORIALS



TUTORIALS


Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Design an appropriate non-clinical development strategy in partnership with

a CRO and to establish a consolidated project• Manage and solve unexpected technical problems and study results in

cooperation with a CRO• Perform fair negotiations about offers and contracts

Target Audience• Colleagues responsible for drug discovery programs and non-clinical

development of drugs especially from start-up companies or small/midsize enterprises; also, colleagues from larger companies which are outsourcing non-clinical studies on a regular basis especially in the later stages of a successful drug development.

Tutorial 07

INTRODUCTION TO MEDICAL DEVICE REGULATION

Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The NetherlandsErik Vollebregt, Attorney, Greenberg Traurig, The Netherlands

This tutorial will give a condensed overview of the EU device legislative system and the principles and philosophy behind it. It will explain the definition of a medical device and also explain risk classification of medical devices and the relation between risk classification and conformity assessment procedures. It will highlight the role of the notified bodies in the system and it will give insight in the legal requirements for clinical evaluation and clinical investigation. Furthermore the tutorial will provide insight in the EU regulation of in vitro diagnostics (IVDs).

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Understand the definition of a medical device• Understand the main characteristics of the EU Medical Device regulatory

system• Understand the main topics of the EU Medical Device Directive (Directive

93/42 as amended by Directive 2007/47)• Understand the system of conformity assessment by Notified Bodies• Understand the principles of risk classification• Understand the legal requirements for clinical evaluation and clinical

investigation• Understand the main characteristics of the EU In Vitro Diagnostic Directive

Target Audience• Professionals in the pharmaceutical area (e.g. regulatory affairs, clinical

development) who are involved in the development and marketing of drug-device combinations

• Professionals in the pharmaceutical area (e.g. regulatory affairs, clinical development) who would like to obtain a condensed overview of the EU Medical Device regulatory system

• EuroMeeting participants who plan to attend the theme “The Drug/Device Boundary: Is it about to Disappear?

Tutorial 08

DATA PRIVACY IN CLINICAL TRIALS AND PHARMACOVIGILANCE

Pierre-Yves Lastic, Senior Director, Data Privacy and Healthcare Interoperability Standards, sanofi-aventis R&D, France

This tutorial will explain:• Why is Personal Data Protection important?• Principles of Personal Data Protection, based on the European Regulations• Overview of worldwide regulations and the differences between them• Specific regulations for biomedical research and pharmacovigilance and their

consequences• How to complyInformation and consentCommunication and trainingIT Security and validationLegal instruments (contracts, Safe Harbor, BCRs)Data Privacy Organisation

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to: • Understand the principles of Personal Data Protection in the European Union• Understand the differences between European, US and Asian data privacy

regulations• Have a basic knowledge of how to comply with European and other

worldwide regulations

Target AudienceAll individuals involved in the organisation and management of clinical trials and pharmacovigilance, or handling with data collected to perform these activities

Tutorial 09

HOW TO PREPARE FOR THE IMPLEMENTATION OF THE NEW ISO/ICH INDIVIDUAL CASE SAFETY REPORT (ICSR) STANDARD IN THE FRAME OF THE ICH GUIDELINE E2B (R3)

Anja van Haren, EudraVigilance Coordinator, Medicines Evaluation Board, The NetherlandsGaby Danan, Expert in Pharmacovigilance, Senior Director, Global Pharmacovigilance and Epidemiology, sanofi-aventis, France

The international standardisation for the new Individual Case Safety Report (ICSR) is rapidly progressing. This standard will provide the format for the electronic transmission of ICSRs by marketing authorisation holders to the European Medicines Agency in accordance with the new provisions resulting from the amendment of Regulation 726/2004 and Directive 2001/83/EC, which was initiated by the European Commission in December 2008 with the goal of strengthening and rationalising the European Community pharmacovigilance system for medicinal products for human use.

This tutorial will provide participants with the opportunity to familiarise themselves the concepts defined in the ISO ICSR standard, to learn how the ISO message exchange standards will be applied and to obtain an understanding on how the standards will be implemented at ICH level in the frame of the guideline E2B (R3).



TUTORIALS

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Recognise the new ISO/ICH ICSR content and message• Compare the current E2B R2 ICSR with the new standard ISO/ICH E2B (R3)• Interpret correctly the new requirements and data elements of the new ISO/

ICH E2B(R3) ICSR

Target AudienceQualified Persons responsible for Pharmacovigilance (QPPVs) and individuals involved in:• Pharmacovigilance• Clinical Data Management• Clinical Development• Information Management• Safety Databases

Tutorial 10

HOW TO PREPARE FOR THE IMPLEMENTATION OF THE ISO/HL7/ICH IDENTIFICATION OF MEDICINAL PRODUCT (IDMP) STANDARDS

Sabine Brosch, Business Lead EudraVigilance and International Standardisation in Pharmacovigilance and Risk Management Sector, European Medicines Agency, EUVada Perkins, Regulatory Program Management Officer, FDA, USA

The international standardisation in the area of the new Identification of Medicinal Products (IDMP) is rapidly progressing. This standard will provide the format for the electronic submission of medicinal product information by marketing authorisation holders to the European Medicines Agency in accordance with the new EU pharmacovigilance legislation.

The ISO IDMP Draft International Standards were released on 23 September 2010 for a five-month ballot and the ICH has initiated testing.

This tutorial will provide participants with the opportunity to familiarise themselves with the concepts defined in the five ISO IDMP standards, to learn how the HL7 message exchange standards will be applied and to obtain an understanding on how the standards will be implemented in the EU and the US. The technical and business process related aspects that need to be taken into account in preparing for a coordinated, well-organised approach in putting the new standards in operation will be also addressed. This also includes the use of the IDMP standards in the context of the new ISO Individual Case Safety Reports (ICSR) standard.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Update on the ongoing international IDMP standardisation work• Recognise the main new features of the five IDMP standards• Recognise the interface of the IDMP and ICSR standards with the new

pharmacovigilance legislation in the EU • Prepare for the implementation of the new IDMP standards in the EU and the

US focusing on potential adaptations to regulatory product management and pharmacovigilance systems

Target Audience• Representatives of IT departments of medicines regulatory authorities,

pharmaceutical companies and service providers• Regulatory affairs staff of pharmaceutical companies• EU Qualified Persons responsible for Pharmacovigilance (EU QPPVs)• Pharmacovigilance staff of pharmaceutical companies and medicines

regulatory authorities• Medicinal product management software vendors• Sponsors of clinical trials

Tutorial 11

TAILORING SERVICE AGREEMENTS IN PRE-CLINICAL R&D TO YOUR NEEDS

Claudia Luetzeler, Attorney, Luetzeler und Partner Rechtsanwaelte, Germany

Pre-clinical research and development often rely on external service providers for the provision of various activities (e.g. performance of toxicity studies, development of companion diagnostics). Any non-legal personnel involved in the negotiation of service agreements with the respective service providers needs a basic understanding of the relevant contractual issues such as identification of regulatory requirements, allocation of arising intellectual property, and scope of warranties and limitation of liability. It is the aim of the tutorial to discuss different and potentially conflicting interests of the parties, mechanisms for their resolution and examples for contractual clauses, also including general aspects that need to be covered in service agreements.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Identify critical legal issues in agreements with service providers in the field

of pre-clinical R&D• Interpret and evaluate typical contractual clauses• Propose and negotiate practical solutions for conflicting interests of the

parties

Target Audience• Any non-legal personnel involved in the negotiation of service agreements

with service providers in the field of pre-clinical R&D

Tutorial 12

UKRAINE, BELARUS, KAZAKHSTAN: FURTHER HARMONISATION OF CLINICAL TRIALS REGULATION - HOW TO BENEFIT?

Andrei Kravchenko, Head of Representative Ukraine Office, Harrison Clinical Research, GmbH, Germany

Ukraine, Belarus and Kazakhstan are countries with different clinical trials markets and environments. Originating from common system of the Soviet Union, each of these countries had their own development including reformation of healthcare systems and set up of local legislations for clinical trials. This tutorial has been designed to describe current status of clinical trials market in each country and demonstrate ways of usage advantages in each of them in the most efficient way.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Describe the status of clinical trial legislation and its impact on the clinical

trials environment in Ukraine, Belarus and Kazakhstan• List the benefits and how to avoid the typical mistakes made, when running



TUTORIALS

clinical trials in Ukraine, Belarus and Kazakhstan. • Demonstrate key factors of success in Ukraine, Belarus and Kazakhstan• Distinguish between clinical trials environments in selected CIS countries• Recognise the strengths of each country and plan operations in or expansion

to Ukraine, Belarus and Kazakhstan using presented experience• Apply knowledge of key success factors of current or planned clinical trials in

Ukraine, Belarus and Kazakhstan

Target Audience• Clinical Operation Managers• Project Managers• Directors of Strategic Development• Managing Directors of CROs and pharma companies planning or expanding

operations to Ukraine, Belarus and Kazakhstan• Other clinical research professionals investigating clinical trials environments

in CIS countries

Tutorial 13

QUALITY RISK MANAGEMENT (QRM): A PRACTICAL GUIDE TO BRINGING A DATA-DRIVEN DECISION METHODOLOGY IN GCP QA AND PHARMACOVIGILANCE ACTIVITIES

Mike Britt, Global Head Systems Validation, Roche Products Ltd, UKVolker Rönicke, Principal, Booz & Company, Germany

Quality Risk Management (QRM) is an innovative solution that extends the use of common risk management methodologies and couples with existing company data sources to deliver a true risk-based approach to GCP QA and pharmacovigilance, with potential for a 100% scope of coverage and oversight. QRM applies prospective management of potential quality, compliance, performance issues before issue manifestation by providing the right quality/compliance fact base to make crucial resource deployment decisions as well as planning and implementing focused mitigating actions.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• State the basic principles of QRM with a view to translating them back into

operational practice within their own companies• Recognise and interpret the benefits of QRM within their own companies

(and potentially beyond)• Propose the formulation and computation of quality metrics (Key Risk

Indicators) within a QRM model which will differentiate between different entities with regards to Quality

• Identify the steps and the approach that must be taken to implement QRM in their organisations

Target Audience• GCP and PV Auditors• CQA Managers• GCP and PV Compliance Managers• GCP and PV Trainers• Study Managers• Monitors/CRAs

Tutorial 14

NON-CLINICAL SAFETY ASSESSMENT OF PHARMACEUTICALS

Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, GermanyGerd Bode, Consultant, Germany

This tutorial has been prepared to provide participants with an overview of the importance of toxicology studies and where they fit in the pharmaceutical development. Participants will be offered the opportunity to discuss the relevant ICH guidelines concerning toxicological disciplines. In addition the problem of impurities in pharmaceuticals and the regulatory requirement will be discussed. Good understanding of the implications of non-clinical data is crucial when designing or preparing a submission dossier including the non-clinical section in the Summary of Product Characterisation (SmPC) for the competent authorities.

Learning ObjectivesAt the conclusion of this tutorial participants will be able to:• Understand the basic principles of non-clinical safety assessment• Recognise the importance of non-clinical studies in the phases of drug

development• Describe the requirements for safety by agencies• Understand the non-clinical section in the SmPC

Target Audience• Non-toxicologists or beginners in toxicology• Regulatory affairs personnel, clinical research• Project team leaders• Regulators with interest in non-clinical safety assessment

Tutorial 15

RISK SHARING AND PATIENT ACCESS SCHEMES – THEIR VALUE IN REDUCING UNCERTAINTY OF THE REAL WORLD BENEFITS OF MEDICINES

François Lucas, Principal Consultant, Pope Woodhead and Associates, UK

Risk-sharing schemes aim to allow access to innovative drugs while reducing financial burden and uncertainty for the healthcare system. Such schemes emerged in response to negative HTA evaluations of expensive drugs with an uncertain clinical and economic evidence basis at launch. In some schemes, payment of the drug is based on its real-world performance; others are financed-based, setting caps on payments or offering free initial treatment. A further dimension is whether the scheme is associated with an observational study or operates at the patient level. This tutorial has an interactive, ‘hands on’ format, and is focused on: understanding the ‘theory’ and range of possible ‘risk sharing’ schemes, evaluating scheme options, managing stakeholder relationships, and implementing feasible and cost-effective schemes.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Describe the theory behind risk sharing and the link to HTA and payer

evaluation • Decide when such an approach is valuable to the healthcare system and

patients• Consider the practical challenges in implementing the schemes



TUTORIALS

Target Audience• Hospital pharmacists• Physicians, in particular oncologists, where this approach is common• Pharmaceutical company executives with responsibility for pricing,

reimbursement and market access

Tutorial 16

INTRODUCTION TO CRISIS MANAGEMENT

Jan-Willem van der Velden, CEO, Founding Director, Mesama Consulting, SwitzerlandMichael Forstner, Integrated Safety Risk Manager, F. Hoffmann-La Roche Ltd., Switzerland

In this introductory tutorial the participant will be made familiar with the definition of a crisis and understand which processes in their own working environment could be vulnerable for possible crises. Examples are given and participants are invited to join in exercises and learn which parties are all involved within and outside their organisation. The participant will be provided with the tools with which to plan for a potential crisis and how to build a preventive strategy. The roles of the Crisis Management Team members are shown and examples are given of right and wrong actions, including attitude towards the media.

Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:• Distinguish between an issue, a risk and a crisis and recognize the flow of

events that lead from an issue to a crisis• Recognise a potential crisis on time and approach a crisis appropriately when

it happens• Set up a crisis team that should be able to deal with the crisis in all its stages

Target Audience• Regulatory authorities • PV experts• Pharmaceutical industry• Medical affairs• Drug safety department• Marketing department• Legal department• Corporate communications department

Tutorial 17

INCENTIVES TO DRUG DEVELOPMENT: EXPAND YOUR REGULATORY INTUITION

Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EUChristelle Bouygues, Regulatory Affairs Advisor, European Medicines Agency, EU This tutorial will present, in the light of an ever-changing EU legislative environment, the recent incentives to drug development which are of scientific, financial and regulatory procedural nature or a combination of those. The tutorial will cover in detail the various data exclusivity provisions, the orphans, paediatrics and ATMPs incentives as well as provide an insight into the experience with the operation of “early access tools” such as the accelerated review, the conditional and exceptional circumstances MAs by EMA/CHMP.

Each aspect will be applied in practice through interactive case studies. Learning ObjectivesAt the conclusion of this tutorial, participants will be able to:

Having a detailed knowledge and early consideration of these incentives and tools should enable the participants to expand their regulatory intuition; as a result:

• Anticipate, plan and streamline the milestones for their drug development and registrations

• Develop a sound regulatory strategy optimizing the use of the various incentives and tools provided for.

• Discuss advantages and disadvantages of different regulatory strategies for their business pipeline with concerned regulatory authorities

Target Audience• All persons involved in business intelligence, regulatory affairs, business

pipeline and regulatory authorities.

First-rate instructors and best-in-class content are what make DIA’s training programmes the highest quality training programmes available anywhere. DIA offers a variety of courses in regulatory affairs, clinical research, non-clinical safety sciences and pharmacovigilance. Benefits include:

• Expert instructors actively practicing in their particular discipline• Continuing education credits • Up-to-the-minute coverage of important industry hot topics • Networking opportunities • Consistent course materials from one offering to another

• Limited attendance allows for a more personal quality learning experience• Tailor-made case studies and instructor-led group work• In-depth discussion of specific contemporary issues

Always Stay One Move AheadWith DIA Training CoursesThe Best Value Training Available Anywhere.

For more information and a complete listing of all training courses, please visit www.diahome.org and click on Training.

16 GREENING THE EUROMEETING

Geneva is a city which takes its responsibility for the environment seriously, from renewable energy production to its efficient public transport system. This

commitment to the environment extends to the Palexpo Convention Centre who share the DIA’s commitment to an environmentally-friendly EuroMeeting.

Waste recycling for some events at Palexpo has now reached levels of nearly 80%. Other measures include the provision of all of Palexpo’s energy needs

by hydro-electric power and/or solar panels on the roof of one of the halls and an electrical charge port for two-wheel vehicles in the parking area which

may be used free of charge.

Using practical, innovative, and often very simple measures, the EuroMeeting’s carbon footprint has been successfully reduced. We will be practicing the

3Rs in Geneva: Reduce, Recycle and Reuse.

We will offer you an environmentally-friendly conference bag when you collect your badge (which of course, we will recycle at the end of the meeting

if you return it to us). Recycling bins will be placed throughout the building. The meeting will be paperless wherever possible, and all EuroMeeting

publications will be printed on FSC-certified paper, which means that they are sourced from well-managed forests and recycled wood.

Working with exhibitors is an important part of the EuroMeeting, and we look forward to a successful partnership in 2011. The Greenest Exhibitor Award,

now in its third year, aims to raise the awareness of exhibitors of this growing movement in the conference and exhibitions industry. We make it easy

for exhibitors to recycle. Additionally, we ensure that stand carpets, for example, are recycled for use in other products such as pots and containers, and

untreated wood is compacted, to be reused as medium-density fibreboard panels used by furniture manufacturers.

The European office members will travel to the 2011 EuroMeeting by train. DIA will offset the air miles of other staff travelling to the EuroMeeting

with a Swiss non-profit foundation, "myclimate" – The Climate Protection Partnership (www.myclimate.org), and we encourage all our participants and

exhibitors to support our greening initiative by considering offsetting their miles. All participants will receive a free Geneva public transport card when

checking in at their hotels. This promotion of public transportation helps to reduce congestion as well as pollution.

We commit to not using disposable cups, plates or cutlery. There will be water coolers throughout the building, reducing the need for individual bottles of

water. Locally grown food will be used wherever possible with participants able to eat healthily as low down the food chain as possible, with vegetarian

options on offer.

If you have any suggestions or creative ideas on how we could do more, please contact Dermot Ryan, EuroMeeting Manager at

[email protected].

GREENING THE EUROMEETING TOWARDS AN ENVIRONMENTALLY FRIENDLY CONFERENCE


THEME 1

Theme 1 | Innovation, Future of Treatment and Personalised MedicineChris Chamberlain, Medical Director, Personalised Medicines, AstraZeneca Pharmaceuticals LP, UKBruno Flamion, Chair Scientific Advice Working Party (SAWP), CHMP; Professor Clinical Pharmacology, University of Namur, Belgium

This theme will reflect on the operational and clinical problems that must be solved to make personalised healthcare a reality for patients. The goal is to signpost the route from the discovery to the clinical utility of novel biomarkers for the enlightenment of all stakeholders in the drug development process. Personalised Medicine represents the systematic attempt better to characterise patients though the application of emerging diagnostic technologies. It is a profoundly patient-centred discipline that applies experimental medicine and biomarker-based analyses to provide new diagnostics and helps deliver meaningful care improvements in real-world practice. The sessions will focus on the challenges of delivering and handling complex data sets in terms of operation and analytical parameters and will look at the emergence of new diagnostic platforms that can provide insights into disease pathology and help define drug response.

Assuring Safety: The role of the non-efficacy biomarkers in PHCAnn Daly, Professor of Pharmacogenetics, Institute of Cellular Medicine, Newcastle University, UK

Innovation through Consortia: IMI Project PROTECTElizabeth Swain, Director, Pharmacovigilance Advocacy and Policy, GlaxoSmithKline, UK

SAFE-T: A Collaborative Venture towards New Safety BMsMichael Merz, Coordinator of the IMI SAFE-T Consortium, Director, Preclinical Safety, Translational Sciences, Novartis Institutes for BioMedical Research, Switzerland

14:00-15:30 Session 0103

DEVELOPING PERSONALISED MEDICINES – DELIVERING THE DIAGNOSTICSSession Chair: Nigel Spurr, PHC Portfolio Expert, Roche Products, UK

The emergence of Personalised Medicine requires new insights into the co-validation of diagnostic and pharmacological products. Planning the co- development of diagnostic products is a growing part of clinical development and requires the entry of new skill sets into development processes.

A Roadmap for PHC: Looking to where drugs and diagnostics meetNigel Spurr, PHC Portfolio Expert, Roche Products, UK

Why is the New Procedure for Qualification of Novel Methodologies for Drug Development at the European Medicinces Agency Important for the Development of Personalised Medicine? Maria Isaac, Scientific Administrator, European Medicines Agency, EU

Managing the PHC Lifecycles – The IRESSA experienceRose McCormack, Clinical Research Scientist, AstraZeneca, UK

16:00-17:30 Session 0104/1104

IN VITRO DIAGNOSTIC (JOINT WITH THEME 11)Session Chair: Mark Hope, Head of Program Management, F. Hoffmann-La Roche AG, Switzerland

Personalised healthcare and drug-diagnostic combination approaches to treatment have become an important focus over the last few years. This session will discuss what is needed to develop a drug and diagnostic approach, including specific considerations for the development of diagnostic approaches for use of point of care diagnostics within a clinical trial and the path to regulatory approval for a drug-diagnostic combination.

Case Study: Development of an IVDStephen Little, Vice President, Personalised Healthcare, Qiagen, UK

Point of Care Testing in Clinical Trials Michael Wickham, Managing Director, Woodley Equipment Company Ltd., UK

Case Study of Regulatory Process of Registration of In Vitro Diagnostic with a Medicinal ProductMark Hope, Head of Program Management, F. Hoffmann-La Roche AG, Switzerland

Tuesday, 29 March 2011

09:00-10:30 Session 0101/0701

TRIAL DESIGN AND INTERPRETATION FOR PERSONALISED HEALTHCARE – DELIVERING C21 DRUG DEVELOPMENT (JOINT WITH THEME 7)Session Chair: Aiden Flynn, Director, Biomarkers and Analytics, GlaxoSmithKline, UK

The emergence of new complex diagnostic technologies challenges traditional ways of interpreting the output from clinical trials. Successful Personalised Medicine relies on our being able to understand exactly what biomarker data is telling us and apply this to clinical development decisions.

Statistic Approaches to Data Analysis for PHC- What does the data tell us? Sue-Jane Wang, Associate Director, Office of Biostatistics, FDA, USA

High Dimensional Data – What do we mean?Bryn Williams-Jones, Associate Research Fellow, Head of e-Biology, Pfizer Global Research & Development, UK

Bio Informatic Tools for Complex DataTom Freeman, Group Leader, The Roslin Institute, R(D)SVS, Division of Genetics and Genomics , University of Edinburgh, UK

11:00-12:30 Session 0102

THE ROLE OF PERSONALISED MEDICINE IN SAFETYSession Chair: Ann Daly, Professor of Pharmacogenetics, Institute of Cellular Medicine, Newcastle University, UK

Personalised Medicine implies better informed prescription through a fuller understanding of risk benefit relationship at the individual level. This calls for a systematic appreciation of the predictability of adverse responses to therapy. Significant progress with the operational issues around collating safety signals for investigation is currently being made through large scale collaborative approaches.


THEME 1 | THEME 2

Wednesday, 30 March 2011

09:00-10:30 Session 0105

HOW TO PAY FOR PERSONALISED MEDICINE? THE VALUE OF STRATIFICATIONSession Chair: Adrian Towse, Director, Office of Health Economics, UK

Ultimately the sustainable delivery of medical innovation is dependent on the provision of sufficient incentives to warrant the considerable operational requirements of medical research and development. The successful prosecution of Personalised Medicine will be reliant on the provision of sufficient value to merit the underlying investment of time and effort required.

Improving Drug Development – Stratification and Drug RescueAdrian Towse, Director, Office of Health Economics, UK

Drug Diagnostic Combinations – Incentives for StratificationFelix W. Früh, Vice President, R&D Personalised Medicine, Medco Health Solutions Inc., USA

Aligning Drug Diagnostic Development – Impact on ValueJames Creeden, Chief Medical Officer, Roche Diagnostics Ltd., Switzerland

11:00-12:30 Session 0106

QUALIFY, VALIDATE, APPLY – ASSURING ASSAY QUALITY THROUGH THE BIOMARKER LIFECYCLESession Chair: Glen Hughes, Associate Director, Translational Sciences and Personalised Healthcare, AstraZeneca, UK

Successful application of our newly acquired insight into the aetiological pathways at play in complex disease is largely predicated on the quantitative assay of a variety of novel biomarkers. Such biomarkers require qualification for this purpose and the qualification cycle needs extend throughout the drug lifecycle.

Moving from Biomarker to ‘Fit for Purpose’ AssayCaroline Dive, Clinical and Experimental Pharmacology Group Leader, Paterson Institute for Cancer Research, UK

The Development of Robust Validated AssaysHenrik Winther, Director R&D, DAKO, Denmark

Assay Deployment from Early Development to Proof of Concept J. Carl Barrett, Global Head of Oncology Biomarker and Clinical Imaging, Novartis Institutes for Biomedical Research Inc., USA

14:00-15:30 Session 0107

CLINICAL UTILITY AND IMPLEMENTATION - THE GATEKEEPER FOR SUCCESSFUL PERSONALISED MEDICINESession Chair: Munir Pirmohamed, NHS Chair of Pharmacogenetics, The University of Liverpool, UK

Despite the technical sophistication of modern biomarker analyses, the rationale for personalised medicine depends entirely on the ability of predictive information to change care pathways. As such assessment of clinical utility remains the primary filter for recognising the value of personalised healthcare projects and should inform consideration of biomarker applications even in the

earliest stages of drug development.

Barriers to Uptake for Personalised Medicine: Understanding the value of stratifications in practiceMunir Pirmohamed, NHS Chair of Pharmacogenetics, The University of Liverpool, UK

Personalised Medicine: Current importance in the frame of drug development programmesIlhan Celik, Senior Director, Head of Biomarker Strategy Oncology,Global Clinical Development Unit, Merck KGaA, Germany

Towards Genotype-Driven Therapy of Colon Cancer Rene Bernards, Chief Scientific Officer, Agendia, The Netherlands

16:00-17:30 Session 0108

PERSONALISED MEDICINES FOR THE REAL WORLDSession Chair: Ron Zimmern, Chairman, PHG Foundation, UK

The emergence of scientific information as to methodologies for patient stratification is just the beginning of the changes that Personalised Medicine will bring to medical practice. Real world examples of stratification and the impact it has on medical practice in a global setting prepare us for the changes engagement with predictive data at the individual level will bring.

Personalised Medicine: An introduction to real-world perspectives and needsRon Zimmern, Chairman, PHG Foundation, UK

Genomics for Health Improvement in Developing Countries Tikki Pang, Director, Research Policy & Cooperation Department, WHO, Switzerland

Personalised Healthcare: A public health perspectiveWalter Ricciardi, Professor, Sacred Heart Catholic University, Italy



09:00-10:30 Session 0201

EVOLUTIONS IN THE EU REGULATORY LANDSCAPESession Chair: Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, Pfizer AB, Sweden

The regulatory environment is highly dynamic with new challenges appearing constantly, which demands that the regulatory framework is able to adapt to changes within reasonable time. The impact on the European regulatory system will be discussed in a panel session by representatives from representatives from the Commission, EMA, a NCA and industry. Examples of topics that may be discussed are: the proportionality of the framework, the many aspects of the globalisation of pharmaceutical operations, the appropriateness of the framework for medicinal product + companion diagnostic, etc.

Patricia Brunko, Head of Unit, European Commission, DG Health and Consumers, EU

Noel Wathion, Head of Patient Health Protection, European Medicines Agency, EU

Susan Forda, Vice President, International Regulatory Affairs, Eli Lilly, UK

Rolf Bass, Professor of Pharmacology and Toxicology, University Berlin - Charité, Germany

Tomas Salmonson, Director Scientific and Regulatory Strategy, Vice-chair CHMP, Medical Products Agency (MPA), Sweden

11:00-12:30 Session 0202/0302

DECISION-MAKING PROCESS OF BENEFIT/RISK ASSESSMENT – A COLLABORATIVE FRAMEWORK APPROACH (JOINT WITH THEME 3)Session Chair: Iman Barilero, Vice President, Regulatory Development Strategy & Policy, H. Lundbeck A/S, DenmarkThe session will provide an opportunity to discuss the CHMP work on methodologies for B/R assessment and address the views from industry and patients.

The use of a consistent and transparent B/R assessment framework for

decision making would facilitate communication of the rationale for decisions, but it should retain sufficient flexibility. An area of potential research is the further development of quantitative tools, which should not lead to a B/R ratio expressed as one single figure.

Another area that requires deep reflection is how the B/R assessment will be applied in the so-called ‘staggered’ approval and how this approach will be integrated in the newly proposed B/R management plan. The implications of such an approach on the R&D investment should be assessed.

CHMP Progress with the Methodologies and Decision-Making of B/R Assessment during the Product LifecycleEric Abadie, Chair, CHMP, Chair Pharmacogenomics Working Party, European Medicines Agency; General Directorate, Afssaps, France

Industry Views on the Way Forward to Support Effective Decision Making of Benefit/Risk Assessment in Context of Global Development ProgrammesIman Barilero, Vice President, Regulatory Development Strategy & Policy, H. Lundbeck A/S, Denmark

Contribution of Patient’s Organisation in the Decision-Making of B/R Assessment Yann Le Cam, CEO, EURORDIS, France

14:00-15:30 Session 0203

STRATEGIES TO OBTAIN COMPETITIVE APPROVALS IN A CHANGING ENVIRONMENTSession Chair: Henrik Kim Nielsen, Corporate Vice President, RA Haemostasis, Novo Nordisk A/S, Denmark

Six presenters will give their input on how to navigate in the current regulatory environments in order to achieve competitive approvals. After a brief presentation by the speakers, they will be available in break-out groups for in-depth discussion of their topic.

A Good Start is Half the Battle: Exploiting the regulatory potential of known active substances by proactive and intelligent strategic planning Sabine Ingrid Hauk, Managing Director, Pharmalex GmbH, Germany Strategies for Navigating the European Regulatory LandscapeVictoria English. Editor, Med Nous, UK

Orphan Designation of Nimorazole as a Hypoxic Radio Sensitiser in the Treatment of HNSCC Patients Undergoing Radiotherapy Hanne Damgaard Jensen, CEO, Regunic, Denmark

Simultaneous Submission in US, EU and Japan Lene Thrane, Regulatory Project Director, Novo Nordisk A/S, Denmark

The Timing of CPP Use and the Impact on Regulatory Approvals and Patient Access to Medicines in the Emerging Markets Lawrence E Liberti, Executive Director, CMR International Institute for Regulatory Science (CIRSI), USA

The Impact of a Rapidly Changing Standard of Care on Regulatory Approval of VotrientSally Bruce, Director, Global Regulatory Affairs, GlaxoSmithKline R&D, UK

THEME 2

Theme 2 | Securing Approvals in a Changing Environment for the Benefit of PatientsHenrik Kim Nielsen, Corporate Vice President, RA Haemostasis, Novo Nordisk A/S, DenmarkTomas Salmonson, Vice Chairman, CHMP, Director Scientific and Regulatory Strategies, MPA, Sweden

This theme will address the changes in the European regulatory environment, discuss the appropriateness of the current level of regulations and suggest some of the strategies the pharmaceutical industry can take to secure competitive approvals. Special aspects of approvals will be addressed in separate sessions: Benefit/risk assessment from a regulatory point of view, advanced therapies, and a review of the recent new approaches to maintaining the approvals (variations). Finally, two sessions will deal with how the regulatory environment is able to meet the needs of the patient both in terms of strategies for making the product available to all patients and how the information need of the patient is met.


The Impact of a Rapidly Changing Standard of Care on Regulatory Approval of VotrientSally Bruce, Director, Oncology Therapeutic Group, Global Regulatory Affairs, GlaxoSmithKline R&D, UK

16:00-17:30 Session 0204

DEVELOPING ADVANCED THERAPY MEDICINAL PRODUCTS – CHALLENGES AND OPPORTUNITIESSession Chair: Catarina Edfjäll, Senior Director, Regulatory Affairs Europe, Celgene International SARL, Switzerland

This session will cover the functioning and experience to date of the work of the EMA Committee on Advanced Medicines on scientific advice and marketing authorisations as well as industry experience with developing ATMPs and interaction with the CAT.

CAT Procedural Updates and ExperiencesMarie-Helene Pinheiro, Scientific Administrator, Regulatory Affairs, European Medicines Agency, EU

Practical Steps towards a Marketing Authorisation for a Gene-Therapy ProductMaureen Graham, Managing Director, Diamond BioPharm Ltd., UK

CAT Experience so FarBeatriz Silva Lima, Chair SWP; Professor, Pharmacology, iMED-UL, Lisbon University and INFARMED, Portugal


09:00-10:30 Session 0205/1405

IMPLEMENTATION OF THE REVISED VARIATIONS REGULATION – ARE THE OBJECTIVES BEING MET? (JOINT WITH THEME 14)Session Chair: Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK

The revised Variations Regulation (EC No. 1234/2008) applied from 1st January 2010 to marketed authorisations granted through a mutual recognition process, decentralised procedure or centralised procedure. The overall objectives of this revision were to provide a simpler, clearer and more flexible legislative framework governing variations.

Based on 15 months' experience, industry and regulatory experts will provide a perspective on whether these objectives are being met. Specific considerations will be given to experience on procedural aspects, managing CMC changes, and implications for e-Submissions.

The Revised Variations Regulation - Are the new ideas at life? Peter Bachmann, Senior Expert, European Drug and Regulatory Affairs, BfArM, Germany

Implementation of the Updated EU Variation Regulation – Simpler, clearer and more flexible? Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, Denmark

Challenges and Opportunities for E-submissionsRemco Munnik, Regulatory Affairs Information Manager, Sandoz, B.V., The Netherlands

11:00-12:30 Session 0206

TOWN HALL MEETING – MEET THE REGULATORSModerator: Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria

In the Town Hall Meeting the attendees can ask burning questions to top decision makers in the European regulatory system. They will include key people from the EMA system and National Health Authorities. Furthermore a representative from patient organisation will also be on the panel.

The topics/questions discussed are decided by the attendees and should be related to:

• Responsibility of the agencies in the EU network• Authorisation and Maintenance of Medicinal Products; Benefit/Risk Methodologies• Pharmacovigilance• International Cooperation and Inspection-Related Issues• Electronic Submission• The Role of Patient Organisations

Responsibilities of the Agencies in the EU NetworkNoel Wathion, Head of Patient Health Protection, European Medicines Agency, EU Aginus Kalis, Chair HMA-MG, Executive Director, Medicines Evaluation Board (MEB), The Netherlands

Authorisation and Maintenance of Medicinal Products; Benefit/Risk MethodologiesHans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Eric Abadie, Chair CHMP, Chair Pharmacogenomics Working Party, General Director, Afssaps, France Truus Janse-de Hoog , Chair CMD(h), Staff member MEB, European cluster, Medicines Evaluation Board, The Netherlands

PharmacovigilanceJune Raine, Director, Chair PhVWP, Director, Division of Vigilance Risk Management of Medicines, MHRA, UK Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU

International Cooperation and Inspection-Related IssuesEmer Cooke, International Liaison Officer, European Medicines Agency, EU

Electronic SubmissionTimothy Buxton, Head of Sector, ICT Development, European Medicines Agency, EUMarcus Muellner, Director, AGES PharmMed, Austria The Role of Patient OrganisationsAlbert Van der Zeijden, Board Member, International Alliance of Patients Organisations, UK

14:00-15:30 Session 0207

MEETING THE INFORMATION NEEDS OF THE PATIENTSession Chair: Trine Moulvad, Vice President, Novo Nordisk A/S, Denmark

How do we secure approvals in a changing environment while meeting the information needs of the patient?

The MAH has to comply with the requirements of the EU readability

THEME 2


Continuing EducationDIA Europe has been allocated for 20 credits from the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians (RCP) of the UK.

DIA Europe's meetings are accredited by the SwAPP (Swiss Association of Pharmaceutical Professionals) Commission for Professional Development and SGPM (Swiss Society of Pharmaceutical Medicine).


09:00-10:30 Session 0301

GLOBALISATION OF SAFETY: PHARMACOVIGILANCE AND DRUG SAFETY IN EMERGING ASIASession Chair: Stewart Geary, Vice President, Eisai Co. Ltd., Japan

This session will present the most recent developments in drug safety management, especially post-marketing pharmacovigilance and risk management, in Asia with special attention to the emerging countries of China and India. The question of gaps in approaches to drug safety internationally will be taken up including how to bridge those gaps to maintain compliance with requirements in Europe and other ICH territories. Special characteristics of safety issues in the Asian region will also be discussed along with their potential impact on drug safety globally.

Bridging the Gaps between the EU and Asia including Japan in Phamacovigilance RequirementsShinya Yamauchi, Operating Officer, Otsuka Pharmaceutical Co. Ltd., Japan

Drug Safety and Pharmacovigilance in IndiaStewart Geary, Vice President, Eisai Co. Ltd., Japan

guideline while Agencies and Health Care professionals work on improving the communication on benefit-risk assessments and information to patients to improve treatment adherence. The session will discuss what information patients really need and how involved patients are in making decisions about their medicines.

How to Comply with the Readability GuidelineDominique Westphal, European Expert, Paul-Ehrlich-Institut (PEI), Germany

Communicating Benefit-Risk Assessments and Information from Agencies and HCPs to PatientsStuart Walker, Founder, CMR International Institute for Regulatory Science, UK

Patients: How involved are they in the decision about their medicines? Lawrence Berry, CEO, Datapharm, UK

16:00-17:30 Session 0208

HOW TO MAKE THE PRODUCT AVAILABLE TO THE PATIENTSession Chair: Katie Harrison, Associate Director Regulatory Intelligence and Policy, Baxter Healthcare LTD., UK

The key need for many patients is to have access to the product. How can this be achieved e.g. through compassionate use programs or early approval options?

Practical Aspects of Managing Compassionate Use Programs – Industry's PerspectiveSpeaker invited

The Changing Environment for Compassionate Use – A Regulators PerspectiveThomas Sudhop, Head of Clinical Trials and Clinical Inspections Unit, BfArM, Germany

What the Patient Needs Jean Mossman, Policy Lead, European Federation of Neurological Associations (EFNA), UK

Panel with Isabelle Moulon, Head of Medical Information, European Medicines Agency, EU

THEME 3

Theme 3 | Patient Safety: From Data Collection and Integration to Benefit/Risk Analysis and Risk MinimisationSabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), The NetherlandsPhilippe Close, Chief Safety Officer, Novartis Pharma AG, Switzerland

In the words of the Institute of Medicine (IOM) report, patient safety is best achieved by adopting a culture of safety across all involved stakeholders. In the past, this culture has been limited to organisational commitments to continually improve safety and to professionals from various disciplines of the health care sector. A mounting challenge faced by all professionals in the field of medicinal products is an ever expanding field that requires gathering and assessing safety data (e.g. globalisation, web media, new databases literature) and organising them into comprehensive safety knowledge that can then turn into actions in the form of risk management with appropriate minimisation activities. Important initiatives are underway to facilitate safety data collection and interpretation including new technologies, safety data sources, legislative changes and scientific developments that aim at improving the benefit/risk balance of drugs. New concepts about benefit/risk assessment are emerging that involve complex and multidisciplinary decision-making processes that rely on iterative interactions between all stakeholders, not just professionals. There is a growing need to integrate both the benefits and the risks during the entire market life of a drug and to communicate the results of such integration to the public as a whole. This includes facilitating the reporting of adverse events on a global basis through as many sources as possible, then managing risks, minimising them effectively (i.e. documented positive outcome) in order to prevent incidents that may cause undue harm, and also communicating safety risks in the context of expected benefits. In providing all these deliverables, pharmacovigilance should now establish stronger connections with patients and their wishes, for instance in terms of communication. The objectives of this theme are to provide the professionals working in this area with the newest insights on gathering the necessary data, to interpret them into the context of benefit, manage them effectively (i.e. with documented positive outcome) and communicate them to a broader public audience including patients.

New at the EuroMeeting

GCP ForumWednesday, 30 March 2011 | 09:00-12:30See page 43 for session details

Town Hall Session: Meet the RegulatorsWednesday, 30 March 2011 | 11:00-12:30See page 7 for session details


Pharmacovigilance in ChinaConny Mo, Head, US Clinical Trial SAE Case Processing Department, Safety Evaluation and Reporting WSRO, Pfizer R&D CO. Ltd. China

11:00-12:30 Session 0202/0302

DECISION-MAKING PROCESS OF BENEFIT/RISK ASSESSMENT – A COLLABORATIVE FRAMEWORK APPROACH (JOINT WITH THEME 2)Session Chair: Iman Barilero, Divisional Director, Regulatory Development Strategy and Policy, H. Lundbeck A/S, Denmark

The session will provide an opportunity to discuss the CHMP work on methodologies for B/R assessment and address the views from industry and patients.

The use of a consistent and transparent B/R assessment framework for decision-making would facilitate communication of the rationale for decisions, but it should retain sufficient flexibility. An area of potential research is the further development of quantitative tools, which should not lead to a B/R ratio expressed as one single figure.

Another area that requires deep reflection is how the B/R assessment will be applied in the so-called ‘staggered’ approval and how this approach will be integrated in the newly proposed B/R management plan. The implications of such an approach on the R&D investment should be assessed.

CHMP Progress with the Methodologies and Decision-Making of B/R Assessment during the Product LifecycleEric Abadie, Chair, CHMP, Chair Pharmacogenomics Working Party, European Medicines Agency; General Directorate, Afssaps, France

Industry Views on the Way Forward to Support Effective Decision Making of Benefit/Risk Assessment in Context of Global Development ProgrammesIman Barilero, Vice President, Regulatory Development Strategy & Policy, H. Lundbeck A/S, Denmark

Contribution of Patient’s Organisation in the Decision-Making of B/R Assessment Yann Le Cam, CEO, EURORDIS, France

14:00-15:30 Session 0303

FROM RMP TO REMS: IS A GLOBAL APPROACH TO RISK MANAGEMENT ACHIEVABLE?Session Chair: Valerie Simmons, EU QPPV Executive, Global Patient Safety, Eli Lilly and Company Ltd., UK

The requirement for effective risk management systems has now been in place for several years since the publication of ICH E2E and other guidelines in the EU, US and other countries. Whilst all stakeholders intuitively agree that risk management principles are the right way forward for optimising benefit risk for patients, the challenge remains for how companies operating in a global environment will ensure consistent standards across multiple countries and regions. In other words how to reconcile EU – RMPs and REMs. This session will examine how globalised risk management planning can be achieved in practice, taking into account transatlantic and new CIOMS initiatives.

Transatlantic Simplification InitiativeValerie Simmons, EU QPPV Executive, Global Patient Safety, Eli Lilly and Company Ltd., UK

Global Approaches to Risk Management PlanningSteven. F. Hobbiger, VP Neuroscience and EU QPPV, Global Clinical Safety and Pharmacovigilance, GSK, UK

Global Consensus on Risk Management - CIOMS IX Panos Tsintis, Medical Advisor, NDA Regulatory Sciences Ltd, UK

Panel discussion with Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, CDER, FDA, USA

16:00-17:30 Session 0304

NEW PHARMACOVIGILANCE LEGISLATION: FACILITATION AND TRANSPARENCYSession Chair: Dolores Montero, Head of the Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Medicines Agency, Spain

The new Directive and Regulation on Pharmacovigilance certainly implies major changes in the way that both regulatory authorities and pharmaceutical companies currently run their activities. This session aims to introduce the main changes of the new legislation on pharmacovigilance to the audience, giving particular emphasis to the changes made for achieving an improvement to the efficiency to the system and the transparency of the decision-taken process.

New Procedures Included in the Legislation Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU

Views of the European ParliamentLinda McAvan, Labour Spokesperson, Member European Parliament, EU

Views of a National Competent Authority Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), The Netherlands


09:00-10:30 Session 0305

PRACTICAL CHALLENGES IN RISK MANAGEMENTSession Chair: Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, CDER, FDA, USA

This session will explores some practical challenges in the design and implementation of risk management measures. Views from industry and regulatory agencies will be presented.

Implementation of Risk Management Plans: Challenges we face todaySabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), The Netherlands

Global Risk Management Management with TYSABRI: Challenges and lessons learnedCarmen Bosic, Senior Vice President and Global Head, Drug Safety Risk Management, Biogen Idec Inc., USA

Risk Minimisation is Just the Beginning: Now implement it!Valerie Simmons, EU QPPV Executive, Global Patient Safety, Eli Lilly and Company Ltd., UK

THEME 3


Since the European Medicines Agency (EMA) put forward its public consultation paper on transparency in June 2009, there have been increased pressure put on the agency and other European pharmaceutical bodies by academics, stakeholders and certain lobbyists to become more transparent with regard to its market authorisation of new medicines. These actors have put forward a series of reasons why pharmaceutical agencies such as the EMA should become more transparent with regard to drug authorisation, noting for example that it:

• would assist independent parties (such as the scientific community) to define the benefit risk profiles of the drug entity in question before it enters the market• would boost the credibility of the EMA• would indicate that EMA sees patients’ interests to be more important than industries’ interests

But is this always the case? Is there an undisputable link between transparency and greater credibility of the regulator? Also, if so, what type of transparency should be used? Should we have a “fish bowl” type of transparency or should we aim for more science based transparency? Finally, can the pharmaceutical sector gain valuable lessons from other sectors that have already undergone greater public and stakeholder scrutiny? To address these and related questions we have assembled an expert panel composed of:

Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU

Terrence Collis, Director of Communications, Food Standards Agency, UK

Deborah Szafir, Head of Safety Risk Management Strategy, Roche, France

THEME 4

11:00-12:30 Session 0306

DATA SOURCES FOR PHARMACOVIGILANCE ASSESSMENTSession Chair: Stephen Evans, Professor of Pharmacoepidemiology, The London School of Hygiene & Tropical Medicine, UK

Signal Detection and Testing: Lessons learnt and current issues Stephen Evans, Professor of Pharmacoepidemiology, The London School of Hygiene & Tropical Medicine, UK

EU_ADR: is it the answer for reliable signal detection?Gianluca Trifiro, Assistant Professor, Medical Informatics, The Netherlands

Systematic Case Control Studies: The Pharmacoepidemiological General Research eXtension (PGRx) ExampleLucien Abenhaim, President, LA-SER Europe Ltd., UK

14:00-15:30 Session 0307

HOW BETTER INCIDENT MANAGEMENT PREVENTS CRISIS: PANEL DISCUSSIONSession Chair: Frederic Bouder, Assistant Professor, Technology and Society Studies, Maastricht University, the Netherlands

The scientific basis for balancing risks and benefits is increasingly challenged in an environment characterised by declining trust in regulators, a more demanding public and a more critical media. If not properly managed, safety events may escalate into full-fudged public controversies. Decisions taken under strain may lead to unbalanced choices that undermine rather than improve patients’ health. The analysis of recent public controversies affecting drugs (Acomplia, Viracept) and vaccines (MMR, Hepatitis B and HPV) suggests that well-prepared regulators manage emergency situation significantly better than unprepared ones. Is it possible to avoid the pitfalls of knee-jerk reaction? Is precaution always the right answer? What are the “do” and “dont's” when confronted to a safety event? This session will address these questions in a meaningful way. It will convey key lessons from state-of-the-art research in the field. A panel of three discussants from the regulatory, medical and patient perspectives will reflect on these key lessons and present best practice illustrations from their own experience of concrete situations. The session will also spell out successful approaches that may be followed when confronted to the more direct involvement of patients. The prevent or mitigation of future crises urgently requires us to deal with safety events more effectively.

The Do’s and Don’ts of Incident Management Frederic Bouder, Assistant Professor, Technology and Society Studies, Maastricht University, the Netherlands

Pat O'Mahony, Chief Executive Officer, Irish Medicines Board, Ireland

Herve Le Louet, Head of Pharmacovigilance Department, University Hospital Henri Mondor, France

David Haerry, Representative, European AIDS Treatment Group (EATG), Belgium

16:00-17:30 Session 0308

RISK COMMUNICATION AND TRANSPARENCY IN THE 21ST CENTURY: LESSONS FOR PHARMASession Chair: Ragnar Lofstedt, Director, The King’s Centre for Risk Management, The International Policy InstituteKing’s College London, UK

Theme 4 | Clinical Study Endpoints and HTA/Cost EffectivenessOlivier Chassany, Professor, Clinical Research & Development Department, Assistance Publique - Hôpitaux de Paris, FranceWills Hughes-Wilson, Senior Director, Health Policy Europe, Genzyme, Belgium

In the context of growing requirements from health authorities, the theme aims to examine the possibilities of increasing the consistency between European Health Technology Assessment (HTA) agencies. It will also explore the potential to reconcile the different requirements for Marketing Authorisation and actual market access, as determined by reimbursement decisions. The second part of the theme focuses in on clinical endpoints. It will examine differences and similarities in the FDA and European Medicines Agency approaches for the assessment of Patient-Reported Outcomes (PROs). It will explore opportunities for further interaction between the agencies themselves and with industry. It will discuss the factors for a successful scientific advice and review the potential of Scientific Advice in the future. Lastly, it will present an update on the different initiatives undertaken by European and US Public-Private Partnerships, to reach consensus on Patient-Reported endpoints.


09:00-10:30 Session 0401

UPDATE ON HOW AGENCIES ASSESS THERAPEUTIC VALUE OF A PRODUCT AND – INCREASINGLY – THE THERAPEUTIC ADDED VALUESession Chair:Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU

Marketing Authorisation is no longer the “key to the market”. Without a successful demonstration that the product can actually add value, reimbursed


market access, or at least, reimbursed market access at a price that makes sense to the manufacturer might be just a dream. This session will examine the approaches that different countries take to not only assess the value that the product brings to the patients, but also what added value it brings, in relation to existing therapeutic options.

Assessment of Pharmaceuticals in France: Actual benefit and therapeutic added valueAnne d’Andon, Head of Medicines Assessment, Haute Autorité de Santé (HAS), France

A Practical Example of Gathering In-Life Outcomes: AIFA’s system Guido Rasi, General Director, Italian Medicines Agency (AIFA), Italy

Therapeutic Added Value and Cost-Effectiveness Assessment in the Pharmaceutical Decision - Making Process in Catalonia Antoni Gilabert Perramon, Managing Director of Pharmaceutical Care and Complementary Benefits, Catalan Health Service, Department of Health, Government of Catalonia, Spain

11:00-12:30 Session 0402

CAN WE MERGE TWO DIFFERENT WORLDS: REGULATORY REVIEW FOR MARKETING AUTHORISATION AND HTA ASSESSMENT FOR REIMBURSEMENT DECISION?Session Chair: Wills Hughes-Wilson, Senior Director, Health Policy Europe, Genzyme, Belgium

As regulatory review becomes just one stage in the process, there is a drive to bring together the scientific reviewers for the regulatory approval and the scientific reviewers for the HTA assessment. The European Medicines Agency sees this as one way forward to address the current fragmentation of the single EU Marketing Authorisation caused by 27 or more post-Marketing Authorisation reviews. But how do the national agencies see it? Is it possible in practice and will it address the communication gap?

‘Not Really’Andras Fehervary, Head Market Access & External Affairs, Novartis Oncology Europe, Italy

‘Maybe’Jiří Deml, Deputy Director, State Institute for Drug Control (SUKL), Czech Republic

‘Yes’Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU

14:00-15:30 Session 0403

COMPARISON OF ENDPOINTS FOR MARKETING AUTHORISATION AND REIMBURSEMENT: HOW CAN WE HARMONISE ASSESSMENT?Session Chair: Mira Pavlovic, Deputy Director, DEMESP, HAS Haute Autorité de Santé, France

The endpoints needed to achieve regulatory approval might not be the same as those that an HTA body is looking for. What are the differences and what needs to be added? Will the two always be different?

Increasing the Interaction between Regulators and HTA bodies: Towards easier access for innovative drugs or an increased burden to industry? Karim Benslimane, Regulatory Intelligence & Policy Manager, H. Lundbeck A/S, France

Integrating HTA Requirements into Drug Development Adam Lloyd, Senior Principal, Health Economics and Outcomes Research, IMS, UK

Harmonising Endpoints with HTA requirements? View from the European Medicines AgencyHans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU

16:00-17:30 Session 0404

CAN WE REACH SOME HARMONISATION ACROSS EUROPE ON HTA REVIEW; ASSESSMENT OF VALUE PRODUCT, ADDED VALUE PRODUCT AND REIMBURSEMENT DECISION PROCESS?Session Chair: Yann Le Cam, Chief Executive Officer, EURORDIS, France

The EUNetHTA project has 'earned its stripes' – it has gone from being a trial project to a full 'Joint Action', 50% funded by the Member States. Will it lead to potential alignment of relative effectiveness, the creation of relative effectiveness guidelines and, ultimately a shared long-term assessment, to support conditional pricing and reimbursement as foreseen by the EU High Level Pharmaceutical Forum?

EU Cooperation on HTAJérôme Boehm, Health and Consumers, Policy Officer in charge of the EU cooperation on HTA and eHealth, European Commission, EU

Can Clear Understanding of Individual EU National HTA Evaluations and Decision-Making Processes Lead to More Predictable, Transparent and Consistent Outcomes?Franz Pichler, Manager HTA Programmes, Centre for Innovation in Regulatory Science Ltd (formerly CMR International Institute for Regulatory Science), UK

From HTA to Reimbursement and Pricing: Situation in France and European perspectiveFrançois Meyer, Director, Health Technology Assessment Division, HAS Haute Autorité de Santé, France


09:00-10:30 Session 0405

FDA GUIDANCE ON PATIENT-REPORTED OUTCOMES AND EMA’S PAPER ON HEALTH-RELATED QUALITY OF LIFE: DIVERGENCES AND INTERACTION SIMILARITIESSession Chair: Olivier Chassany, Professor, Clinical Research & Development Department, Assistance Publique - Hôpitaux de Paris, France

Both FDA and the European Medicines Agency (EMA) have developed guidance on the use of Patient-Reported Outcomes (PROs). Will this support global development and what are the areas of similarity, difference and opportunities to interact with both agencies?

Harmonising Study Endpoints for Multi-National Clinical TrialsLaurie Burke, Director, Study Endpoints and Labeling, Office of New Drugs, CDER, FDA, USA

Harmonising the Final FDA Patient-Reported Outcomes Guidance and the EMA “Points to Consider” Document – What is the best way forward? Ingela Wiklund, Senior Research Leader, United Biosource Corporation, UK

Impact of Health-Related Quality of Life Data (HRQL) on Health Technology Assessment (HTA) Process in FranceSophie Stamenkovic, Project Leader, HAS Haute Autorité de Santé, France

THEME 4


11:00-12:30 Session 0406

ASSESSING SYMPTOMS IN GLOBAL CLINICAL TRIALS TO MEET FDA AND EUROPEAN MEDICINES AGENCY STANDARDSSession Chair: Laurie Burke, Director, Study Endpoints and Labeling, Office of New Drugs, CDER, FDA, USA

There is an increasing need for international clinical trials in order to gather together the necessary patient populations and numbers. How do the FDA and the European Medicines Agency’s symptom assessment standards facilitate such international clinical trials? Value of Evaluating Symptom Endpoints: Labels and BeyondLena Ring, Associate Professor, Uppsala University and Principal Scientist, Health Economics & Outcomes Research, AstraZeneca, Sweden

The Regulatory Perspective: EU and US: Is a global assessment valid?Olivier Chassany, Professor, Clinical Research & Development Department, Assistance Publique - Hôpitaux de Paris, France

Meeting Regulatory Requirements in International Trials (including content validation – PRO issues)Károly Kulich, PRO Expert, Novartis Pharma AG, Switzerland

14:00-15:30 Session 0407

SCIENTIFIC ADVICE ON ENDPOINTS: TO COMPLY OR NOT TO COMPLYSession Chair: Alicia Granados, Senior Director Global HTA Strategy, Genzyme, Belgium

The value of Scientific Advice has been clearly demonstrated over its years of development. However, are there situations where an applicant should consider to comply or not to comply with Scientific Advice? And what is the impact?

Should You Comply with the Scientific Advice-Requested Endpoint?Bruno Flamion, Immediate Past Chair Scientific Advice Working Party (SAWP), CHMP; Professor Clinical Pharmacology, University of Namur, Belgium

Predictive Factors for a Successful Scientific Advice: Perspective from a from a CRO specialised in PRO Katarina Halling, Senior Scientist, PRO Consulting, Sweden

Scientific Advice on PRO Endpoints: Some Experiences and Thoughts from an Industry PerspectiveMaggie Tabberer, Global Health Outcomes, GlaxoSmithKline, UK

16:00-17:30 Session 0408

PUBLIC-PRIVATE PARTNERSHIPS – INITIATIVES TO REACH CONSENSUS ON PATIENT-REPORTED ENDPOINTSSession Chair: Michel Goldman, Executive Director, Innovative Medicines Initiative (IMI), Belgium

European Innovative Medicines Initiative on Chronic Pulmonary Disease (COPD)Katja Rüdell, Associate Director, Patient Reported Outcomes Centre of Excellence, Pfizer Ltd, UK

US PRO Consortium Initiative on Irritable Bowel Syndrome (IBS)Stephen Joel Coons, Director, PRO Consortium, Critical Path Institute, USA


09:00-10:30 Session 0501

SWITCHING: IS THERE AN IDEAL ROUTE? Session Chair: Hubertus Cranz, Director-General, AESGP, Belgium

This session will review the existing procedures (CP, DCP-MRP, national) that can be used to switch a medicine, the conditions to be met and their pros and cons in terms of resulting access, resources needed etc. What are the influencing factors companies consider when choosing their ‘switching pathway’ and what would be needed to make it the 'perfect route(s)'. These views will be confronted with that of the authorities at national and EU level.

The Centralised Procedure and SwitchEric Abadie, Chair, CHMP, Chair Pharmacogenomics Working Party, European Medicines Agency; General Directorate, Afssaps, France

View of a National AuthorityJune Raine, Director, Division of Vigilance Risk Management of Medicines, MHRA, UK

What are the Important Factors when Selecting a Procedure?Graham Parr, Assistant Vice President, European R&D, Pfizer Consumer Healthcare, UK

11:00-12:30 Session 0502

ARE NEW SWITCHES IN LINE WITH THE EXPECTATION OF THE 'EMPOWERED PATIENT'? Session Chair: Isabelle Moulon, Head of Medical Information, European Medicines Agency, EU

A number of new switches-in-class have born lately in the field of migraine, obesity, BPH, etc. Are these meeting patients' expectations? How is patient need/expectation known? What are consumers after? Are there gaps not met in terms of self-care? What are the criteria that matter for consumers and patients in a switching process both by industry and regulators? All these challenging questions will be addressed in this session giving a prominent role

THEME 5

Theme 5 | Wider Access (Generics/Switching)Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, AustriaChristelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, Belgium

How can we meet the patients' need and expectations? This question will be analysed for generics and self-care medicine. The efficiency of the existing regulatory system (licensing procedures, handling of the lifecycle, switch-procedures) will be discussed. Pros and cons will be identified in order to optimise access to medicines - also in developing countries – as well as affordable treatment by generics and biosimilars; with a high level of information to patients and consumers, which is especially important for non-prescription medicines. The impact of the new changes in the pharmaceutical landscape – a new Directorate General (DG), a new European Commissioner, new strategic roadmaps as well as new pieces of legislation – will be elucidated.

Collaborative Efforts for Developing Patient-Reported Outcome Tools- Examples, opportunities, challenges Asha Hareendran, Senior Research Scientist, United Biosource Corporation, UK


to patients and consumers.

The Patient’s Point of View Ian Banks, President, European Men’s Health Forum, UK

Switch: What could be on the horizon? Stephen Mann, Pharmaceutical Consultant, Co-Editor, SelfCare Journal, UK

Industry ViewSpeaker invited

14:00-15:30 Session 0503

CHANGING REGULATORY ENVIRONMENT: IMPACT ON THE SELF-CARE SECTORSession Chair: Shirley Norton, Deputy Director, Vigilance and Risk Management Division, MHRA, UK

The last year or so have brought a number of changes in the pharmaceutical landscape: a new commissioner, a new DG, new strategic direction of the Agency and of the HMA, early experience with the variation regulation and planned new legislation in pharmacovigilance and in the context of falsified medicines. The session will reflect on the impact these changes may have on the self-care sector and how it may adapt.

Impact of New Legislation on a Changing Regulatory EnvironmentIrene Sacristán Sánchez, Deputy Head of Unit - Pharmaceuticals C8, DG Health & Consumers, European Commission, EU

Reflections of a Member State on the Impact of the Pharma Package on the Self-Care SectorChrister Backman, EU Coordinator and Senior Expert, Medical Products Agency, Sweden

Will the Self-Care Industry be Better Off?Glenn Carpenter, Senior Director, Regulatory Affairs- EMEA, Johnson and Johnson, UK

16:00-17:30 Session 0504

IS THE PATIENT/CONSUMER ADEQUATELY INFORMED?Session Chair: Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU

We are witnessing a breathtaking evolution of new forms of digital communication. All of this is unfolding so quickly that we do not have time to pause and reflect on what is happening. Providing 'the right information, in the right place, at the right time' is even more crucial in a non-prescription environment where the intervention of a healthcare professional is optional. This session therefore proposes to explore amongst industry, regulators and consumer organisations ways to improve the quality of the conventional forms of communication on non-prescription medicines, to debate ways to disseminate such information more effectively and the potential for individualising such information to the consumer/patient needs.

Industry ViewHelen Darracott, Director of Legal & Regulatory Affairs, PAGB, UKThe Regulators’ PerspectiveIsabelle Moulon, Head of Medical Information, European Medicines Agency, EU

Consumers’ PerspectiveIlaria Passarani, Health Policy Officer, BEUC -The European Consumers’ Organisation, Belgium


09:00-10:30 Session 0505

SUPPLY OF QUALITY MEDICINES TO DEVELOPING COUNTRIES Session Chair: Milan Smid, Technical Officer, Prequalification of Medicines Programme, WHO, Switzerland

Needs of essential medicines and procurement by international organisations will be presented to explain opportunities of involvement in supplies to developing countries. QA policies of international organisations, mechanisms of WHO prequalification and EU ‘Article 58’ assessment will be discussed.

Availability and Quality of Medicines in Low Income Countries: The role of European manufacturersHiiti Sillo, Director General, Food and Drug Authority, Tanzania EU Contribution to the Availability of Medicines in Low Income CountriesEmer Cooke, International Liaison Officer, European Medicines Agency, EU WHO Prequalification Programme for Essential Medicines as the Opportunity for ManufacturersLembit Rago, Coordinator, Quality Assurance and Safety, Medicines, Policy, and Standards, WHO, Switzerland Panel with Sophie Logez, The Global Fund to fight AIDS, Tuberculosis and Malaria, Switzerland and Lorenzo Witherspoon, UNITAID, Switzerland

11:00-12:30 Session 0506

HOW TO INCREASE ACCESS TO BIOSIMILAR MEDICINES Session Chair: Suzette Kox, Senior Director, Scientific Affairs, EGA, Belgium

This session looks at the reasons for the generally slow introduction of biosimilar products into clinical practice and discusses approaches on how this new class of products should be optimally regulated in order to deliver the maximum benefit to society and patients. Views from the European Commission - DG Enterprise and Industry, national authorities and the biosimilar medicines industry will be presented.

European Commission DG Enterprise and Industry Views and Activities on How to Increase Access to Biosimilar Medicines Christophe Roeland, Policy Officer, DG Enterprise & Industry, European Commission, EU

Perspective of a Member State’s Medicines AgencyJytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark

How to Increase the Introduction of Biosimilar Medicines into Clinical Practice: A biosimilars manufacturer’s point of viewSandy Eisen, Chief Medical Officer, TEVA Pharmaceuticals Europe, UK

THEME 5



09:00-10:30 Session 0601

INTERNATIONAL STRATEGY FOR NON-CLINICAL CONSULTANTSSession Chair: Elisabeth C. Goodman, Principal Consultant, RiverRhee Consulting, UK

This session presents three case studies which address respectively: The challenges of building a non-clinical drug safety business in an international context; how using an organised global network of expert level consultants can facilitate successful navigation of the regulatory requirements for entry into Phase 1; and how a CRO can engage its whole organisation in creating greater value for its customers, streamlining its processes and building a stronger people and culture infrastructure.

International Strategy: Experience of a Non-clinical CRORoy Forster, Scientific Director, CIT, France

Using an Organised Global Network of Experts to Address Regulatory Requirements for Entry into Phase 1Maurice G. Cary, CEO and founder, Pathology Experts LLP, Switzerland

Building Quality in a Time of ChangeMark S. Duxon, Chief Executive Officer, Porsolt and Partners Pharmacology, France

11:00-12:30 Session 0602

NON-CLINICAL EVALUATION OF DRUG-INDUCED HEPATOTOXICITYSession Chair: Beatriz Silva Lima, Chair SWP; Professor, Pharmacology, iMED-UL, Lisbon University and INFARMED, Portugal

Hepatotoxicity constitutes one of the major causes for late attrition during the development process of pharmaceuticals. In addition, many drugs have been withdrawn from market due to liver toxicity. The need for earlier and better prediction is needed. Recently, the EMA/CHMP/SWP issued a discussion paper where the approaches and strategies for prediction of hepatotoxicity in animal studies are discussed. The session will address current discussions and progress in the area. The views of industry and regulatory scientists will be explained

Impact of Hepatotoxicity on the Attrition of Drug Development - Lessons learned in the post-marketing settingMarkku Pasanen, Professor, University of Eastern Finland, Finland

14:00-15:30 Session 0507

HOW TO IMPROVE THE CURRENT REGULATORY FRAMEWORK IN ORDER TO INCREASE ACCESS TO GENERIC MEDICINESSession Chair: Beata Stepniewska, Director of Regulatory Affairs, EGA, Belgium

The possibility to provide EU citizens with affordable treatment by generic medicines on the next day following patent expiry should be in the interest of all involved parties: patients, healthcare professionals, health authorities and industry. To achieve this objective, there is a need for an efficient regulatory system allowing access to the market in a timely manner. The objective of the session is to discuss possible ways to remove the hurdles and to create a clear, open market that will benefit patients, spur innovation and generate considerable savings with the view to maintaining a sustainable EU healthcare system.

The point of view of a representative of the competent regulatory authority and the generic medicines industry will be presented, followed by a panel discussion with additional panelists from the European Commission and a consumer organisation.

Possible Ways to Improve the Current Regulatory Framework for Generic Medicines:

Industry ViewBeata Stepniewska, Director of Regulatory Affairs, EGA, Belgium

The Regulator’s PerspectiveTruus Janse-de Hoog , Chair CMD(h), Staff member MEB, European Cluster, Medicines Evaluation Board, The NetherlandsZaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU

Panel Discussion with Ilaria Passarani, Health Policy Officer, BEUC -The European Consumers’ Organisation, Belgium

16:00-17:30 Session 0508

PROS AND CONS OF THE CURRENT DECENTRALISED PROCEDURE FOR GENERIC APPLICATIONSSession Chair: Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria

The current European regulatory framework offers different approaches for marketing authorisation applications (e.g. CP, DCP) for generic medicinal products. The complexity of continuously changing regulatory requirements (e.g. guideline for BE-studies, new variation regulation, pharma package) applicable to generic applications will be discussed and the latest updates presented.

Current Regulatory Requirements for Generic Applications – A practical approach Maren Von Fritschen, Director Regulatory Affairs, PharmaLex, Germany

BE-Studies – The key document in generic applications! Experience with the new guideline

Industry Point of ViewJulie Marechal-Jamil, Senior Manager Regulatory Affairs, EGA , Belgium

Authority Point of ViewJan Welink, Vice-chair of the Pharmacokinetic Working Party, EMA, Senior Pharmacokinetic Assessor, Medicines Evaluation Board, The Netherlands

THEME 6

Theme 6 | Engaging the Research World! Non-Clinical Research and DevelopmentPer Spindler, Director, Biopeople, University of Copenhagen, DenmarkNancy Claude, Director of Drug Safety, IRIS, France

Pre-clinical research and development is central to product innovation in the healthcare business. The stakeholders involved are academics, contract research, regulators and industry. They need in many cases to work together to leverage on synergies enabling smarter and faster early product development. Product innovation in our sector is massively embedded in regulatory and streamlined processes; however to do the early steps smarter and faster the research world must be engaged. A pallet of contemporary topics have been selected that will guide and inspire you in the pre-clinical research and development of novel healthcare products.


Reinforcing the Predictive Role of the Non-Clinical Testing: The CHMP/SWP discussion paper on hepatotoxicityKlaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany

The Joint Efforts of Industry and Academia to Reinforce Hepatotoxicy Prediction Including the Value of Regulatory MeasuresStéphane Dhalluin, Director, Investigative Non-Clinical Safety, UCB, Belgium

14:00-15:30 Session 0603/1303

SAFETY ASPECTS IN THE DEVELOPMENT OF VACCINES (JOINT WITH THEME 13)Session Chair: Jan Willem van der Laan, Senior Assessor Section on Safety of Medicines and Teratology Centre, National Institute for Public Health and the Environment (RIVM), The Netherlands

There is an increasing awareness that vaccines have their own characteristics in safety aspects. The recent introduction of adjuvants in marketed products has underlined this. The risk of an increase in autoimmune phenomena and the safe use of vaccines during pregnancy are hot topics. The WHO will present its perspective on the use of adjuvants.

WHO Perspective on Adjuvants in VaccinesMartin Howell Friede, Technical Officer, Initiative for Vaccine Research, WHO, Switzerland

Adjuvants and the Potential Risk of AutoimmunitySarah Gould, Non Clinical Safety Division, Sanofi Pasteur, France

Vaccines and PregnancyJan Willem van der Laan, Senior Assessor Section on Safety of Medicines and Teratology Centre, National Institute for Public Health and the Environment (RIVM), The Netherlands

16:00-17:30 Session 0604

BIOBANKING: LOGISTICS AND SAMPLES HANDLINGSession Chair: Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services GmbH, Germany

Handling frozen specimens is of increasing importance in clinical research. This session willo present strategies and solutions in order to ensure both that frozen specimens are correctly collected, shipped and stored and that these samples arrive in stable condition at the laboratory where reliable lab results are expected.

A Biopharmaceutical Company Perspective: Strategies for improving the management of global samples Julie Corfield, Biobank Head, AstraZeneca R&D, UK

A Biorepository Perspective: How the development of global standards for sample management could improve clinical trial outcomes Lori Ball, Chief Operating Officer, BioStorage Technologies, USA

A Central Laboratory Perspective: How to successfully handle pre-analytical factors such as logistics and frozen storage to achieve reliable laboratory results Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services GmbH, Germany


09:00-10:30 Session 0605

NON-CLINICAL ASPECTS OF FIRST-IN-HUMANSSession Chair: David Jones, Expert Pharmacotoxicologist, MHRA, UK

The session will cover non-clinical support for first-in-human trials, including first-in-paediatrics clinical trials.

Non-Clinical Aspects of First-In-Humans – Has ICH M3R2 made any difference?David Jones, Expert Pharmacotoxicologist, MHRA, UK

First-In-Paediatrics Trials – Are studies in juvenile animals ever needed?Paul Baldrick, Head of Regulatory Affairs, Covance, UK

First-In-Human Trials with Biological CompoundsMaggie Dempster, Safety Assessment, GlaxoSmithKline, UK

11:00-12:30 Session 0606

BIOMARKERS IN NON-CLINICAL SAFETY ASSESSMENTSession Chair: Gerd Bode, Consultant, Germany

The session will provide a comprehensive introduction and global status on the topic and preferably provide one or more examples of biomarkers developed for use in non-clinical safety assessment.

Qualification of Safety Biomarkers for Use in Early Drug Development Peter Kasper, Scientific Director, BfArM, Germany

Cardiac Biomarkers in Non-Clinical Safety StudiesTanja S. Zabka, Global Safety Biomarker Lead, Senior Veterinary Pathologist, Roche Pharmaceuticals, USA

Biomarkers for Biotech CompoundsJennifer Sims, Head of Biologics Safety & Disposition, Novartis Pharma AG, Switzerland

14:00-15:30 Session 0607

THE NON-CLINICAL DEVELOPMENT OF ANTI-CANCER PHARMACEUTICALSSession Chair: Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany

The new ICH S9 guideline on “Non-Clinical Development of Anticancer Pharmaceuticals” will be presented and information will be given to assist in the design of an appropriate program of pre-clinical and clinical studies for the development of anti-cancer drugs.

ICH S9: Non-clinical Development of Anti-cancer PharmaceuticalsKlaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany

Industry Experience with Non-clinical Development of Anti-cancer DrugsHermann Schweinfurth, Head of Non-Clinical Drug Safety, Bayer Schering Pharma AG, Germany

THEME 6 | THEME 7


Challenges for the Non-Clinical Safety Assessment of Anti-Cancer BiologicsJean-Jacques LeGrand, Director of Toxicology, CIT, France

16:00-17:30 Session 0608

CONTEMPORARY ISSUES IN NON-CLINICAL DEVELOPMENT OF BIOTECHNOLOGY-DERIVED PRODUCTSSession Chair: Session Chair: Jennifer Sims, Head of Biologics Safety & Disposition, Novartis Pharma AG, Switzerland

This session will review the progress of the appendix to the ICH S6 guideline and provide several case studies to illustrate and guide on the principles of safety assessment of biopharmaceuticals

ICH S6 R(1) Progress, Hurdles and Outstanding IssuesJan Willem van der Laan, Senior Assessor Section on Safety of Medicines and Teratology Centre, National Institute for Public Health and the Environment (RIVM), Rapporteur for ICH S6 Appendix, The Netherlands

Case Studies Relating to Species Selection, Study Design and ImmunogenicityJennifer Sims, Head of Biologics Safety & Disposition, Novartis Pharma AG, Switzerland

Optimal Reproductive Toxicity Strategies for BiopharmaceuticalsJane Stewart, Director of Reproductive Toxicology, AstraZeneca, UK

Statistic Approaches to Data Analysis for PHC- What does the data tell us? Sue-Jane Wang, Associate Director, Office of Biostatistics, FDA, USA

High Dimensional Data – What do we mean?Bryn Williams-Jones, Associate Research Fellow, Head of e-Biology, Pfizer Global Research & Development, UK

Bio Informatic Tools for Complex DataTom Freeman, Group Leader, The Roslin Institute, R(D)SVS, Division of Genetics and Genomics , University of Edinburgh, UK

11:00-12:30 Session 0702

QUANTITATIVE APPROACH FOR BENEFIT/RISK – CHALLENGES AND OPPORTUNITIESSession Chair: Stephen Evans, Professor of Pharmacoepidemiology, The London School of Hygiene & Tropical Medicine, UK

Benefit/risk decisions rely on the qualitative evaluation of quantitative approaches applied to the wealth of data collected in clinical trials and epidemiological studies. It is hypothesised that decision making can be better informed and made with greater consistency and transparency if quantitative methods are also applied to the benefit-risk trade-off, even if expert judgement remains the cornerstone of decision making. The latest thinking on methodological approaches to this problem will be presented and discussed.

Current Methodological Approaches to Benefit- Risk Decision-Making Deborah Ashby, Professor Medical Statistics, University of London, Bart's and the London Queen Mary's, School of Medicine and Dentistry, UK

Benefit-Risk Assessment of Multiple Sclerosis Treatments: Lessons learnt in the use of multi-criteria decision analysisRichard Nixon, Statistician, Modeling & Simulation, Novartis Pharma AG, Switzerland

From Vision to Reality: Considerations for implementing a quantitative benefit-risk assessment George Quartey, Safety Statistical Expert, Roche Products Ltd, UK

14:00-15:30 Session 0703

RECENT DEVELOPMENTS IN SOFTWARE SOLUTIONS FOR ADAPTIVE TRIAL DESIGNSSession Chair: Frank Bretz, Hannover Medical School, Germany / Novartis Pharma AG, Switzerland

Adaptive designs have received increasing attention because of their potential to enable more efficient drug development, especially in view of the recently released draft FDA guidance on this topic. In the recent past, software solutions for adaptive trial designs have been released, which address different questions and target different development phases. With the proposed session we would like to bring key players together to contrast open source vs. commercial solutions for exploratory vs. confirmatory adaptive trial designs.

Open Source Software Solutions for Exploratory StudiesBjörn Bornkamp, Development Statistical Methodology, Novartis Pharma AG, Switzerland

Commercial Software Solutions for Exploratory StudiesTom Parke, Head of Clinical Trials Solutions, Tessella Support Services, UK

Open Source Software Solutions for Confirmatory StudiesTim Friede, University of Göttingen, Germany

THEME 7

Theme 7 | Statistics across the Drug LifecycleJürgen Kübler, Global Head, Statistical Safety Sciences, Novartis Pharma AG, SwitzerlandRobert Hemmings, Statistics Unit Manager, MHRA, UK

The current R&D process is facing significant challenges: There is a need to develop efficacious and acceptably safe drugs more efficiently, and to improve in the early identification of drugs that will ultimately fail to prove a favourable benefit/risk profile. Sound statistical methods can play a major role in systematically generating knowledge in terms of both design and conduct of an individual study, and design and decision making across the entire lifecycle of a medicinal product. This theme will explore statistical approaches to improve the efficiency with which medicines are developed and monitored. This includes a thorough discussion of how to optimise implementation of established and new methodology and their applicability in a highly regulated environment. The theme aims to provide a forum for discussion between industry, academic and regulatory thought leaders. Relevant experience will be shared and discussed, reflecting on lessons learned. Recommendations for best practice will be developed.


09:00-10:30 Session 0101/0701

TRIAL DESIGN AND INTERPRETATION FOR PERSONALISED HEALTHCARE – DELIVERING C21 DRUG DEVELOPMENT (JOINT WITH THEME 1)Session Chair: Aiden Flynn, Director, Biomarkers and Analytics, GlaxoSmithKline, UK

The emergence of new complex diagnostic technologies challenges traditional ways of interpreting the output from clinical trials. Successful Personalised Medicine relies on our being able to understand exactly what biomarker data is telling us and apply this to clinical development decisions.


Commercial Software Solutions for Confirmatory StudiesGernot Wassmer, ADDPLAN, Germany

Discussion with Sue-Jane Wang, Associate Director, Office of Biostatistics, FDA, USA

16:00-17:30 Session 0704

DESIGNING CLINICAL TRIALS IN A GLOBAL WORLDSession Chair: Jorgen Seldrup, Senior Strategic Biostatistics Director, Quintiles, France

Clinical ViewNigel Rulewski, Quintiles, USA

Statistical ViewPhilip Hougaard, Biostatistics Department, Lundbeck A/S, Denmark Regulatory ViewAndrew Thomson, Statistical Assessor, MHRA, UK


09:00-10:30 Session 0705

USING INDIRECT COMPARISONS IN ASSESSMENT OF CLINICAL DATASession Chair: Michael K. Williams, Safety Data Expert, GlaxoSmithKline, UK

As the requirement for cost-effectiveness and risk/benefit analysis grows, it is important that the statistician takes into account all the information that is available from a variety of sources, to ensure we have as complete a picture as possible. This often means combining results or data from diverse sources, which may prove difficult unless we use indirect comparisons. In this session, three examples of how this methodology has been applied will be presented to show how it is possible to combine this data and obtain an accurate estimate of treatment effects.

Indirect Comparisons in Cost-effectivenessSpeaker invited

Meta-Analyses With Indirect Comparisons: An overview about methods and problems Ralf Bender, Head of Medical Biometry Department, Institute for Quality and Efficiency in Health Care (IQWiG), Germany

The Role of the Statistician in Indirect Comparisons: A Case Study James Matcham, Director Biostatistics, Amgen Ltd, UK

11:00-12:30 Session 0706

COMMUNICATING COMPLEX STATISTICAL RESULTSSession Chair: Ragnar Lofstedt, Director, The King’s Centre for Risk Management, The International Policy InstituteKing’s College London, UK

Drug development is a complicated process, involving complex statistical methodology and difficult, subjective decision making. A key skill for the statistician is to be able to communicate their methods and findings with colleagues from other disciplines and, as part of a multi-disciplinary team, to communicate results to external stakeholders, including patients. This session will look into the types of communication problems facing statisticians and will explore possible solutions and best practices

Quantitative, Informed Decision MakingMichael Branson, IIS Franchise Head, Translational Sciences, Novartis Pharma AG, Switzerland

Using Simulations to Communicate the Expected Consequences of Planned Statistical Analyses Tom Parke, Head of Clinical Trials Solutions, Tessella Support Services, UK

Complex Statistical Methods – What really matters Simon Day, Statistical Expert, Roche Products Ltd., UK

14:00-15:30 Session 0707/0907

STATISTICAL COMPUTING: PROGRESS IN COMPUTATIONAL SCIENCE IN CLINICAL TRIALS (JOINT WITH THEME 9)Session Chair: Joachim Vollmar, Executive Consultant, International Clinical Development Consultants LLC, USA

One of the most important and unrecognised issues contributing to drug development time and regulatory quality is the ability to acquire, store, analyse, share and report information needed to make the most informed and rapid decisions in pharmaceutical companies, contract research organisations, and international regulatory agencies. This session will review the current state of data standards, and analytical/graphical tool development, as well as user experiences and expectations.

Computational Sciences Initiatives - Improving tools, processes and standards for the statistical review of NDAs and BLAsStephen E. Wilson, Director, Division of Biometrics III, CDER, FDA, USA

Dynamic and Interactive Tools Michael O’Connell, Director, Life Sciences, TIBCO, USA

Graphics Fabrice Bancken, Expert in Quantitative Safety, Novartis Pharma AG, Switzerland

16:00-17:30 Session 0708

SUBGROUP ANALYSES Session Chair: Sue-Jane Wang, Associate Director, Office of Biostatistics, FDA, USA

Interpreting subgroups is a notoriously unreliable undertaking, yet discussion of subgroups plays a key role in the interpretation of clinical trial data as trial sponsors search for patients with improved efficacy or reduced harm and regulators concern themselves with patient groups where benefit/risk appears to be less favourable. The CHMP released a concept paper announcing the intent to develop guidance in this area. This session will present case studies as an introduction to the problem, an overview of the planned guidance, and perspectives from industry and academia on this perennial problem.

Academia Perspective Armin Koch, Head of Institute of Biometry, Hannover Medical School, Germany

Is There a Need for Subgroup Analyses? Gerd Karl Rosenkranz, Scientific Officer, Biostatistics, Novartis Pharma AG, Switzerland

Interpretation of Subgroup Analyses in the Context of ReimbursementRalf Bender, Institute for Quality and Efficiency in Health Care (IQWiG), Germany

THEME 7 | THEME 8



09:00-10:30 Session 0801

INCREASING GLOBAL REGULATORY DIALOGUESession Chair: Emma Du Four, Director, Regulatory Policy & Intelligence, Abbott Laboratories, UK

Globalisation of paediatric development is necessary to make medicines available to children in need and to ensure that sufficient trial participants can be recruited in order to generate scientifically robust data. Convergence and acceptability of regulatory requirements is a pre-requisite to avoid unnecessary repetition of clinical trials in children. This session will inform participants about the latest developments from increasing global regulatory dialogue.

FDA Involvement in Global Regulatory DialogueDianne Murphy, Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA, USA

European Medicines Agency Involvement in Global Regulatory DialogueAgnès Saint-Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU

Paediatric Regulatory Network and Global OutreachSuzanne Hill, Scientist, Medicines, Access and Rational Use, Essential Medicines and Pharmaceutical Policies, WHO, Switzerland

11:00-12:30 Session 0802

WILL MODELLING AND SIMULATION ACCELERATE DRUG DEVELOPMENT FOR CHILDREN?Session Chair: Thomas Severin, Medical Scientific Expert, Novartis Pharma AG, Switzerland

The aim of both EU and US paediatric legislation is to allow children to benefit as early as possible from pharmaceutical progress and to prevent them from exposure to unnecessary clinical trials. Modelling and simulation (M&S) is often mentioned in this context. Due to the differences in the pharmacokinetics (PK) and/or in the PK-PD relationship between adults and children, dose selection in paediatric clinical trials remains a challenge. The ICH E11 guideline specified that extrapolation of efficacy for dose selection is justified in drugs where the indication, disease process and outcome of the therapy are likely to be comparable in adults and children. M&S plays an important role in providing dosing regimen recommendations in children as it is a powerful tool suitable for the analysis of the sparse data as collected in the paediatric trials. The scientific challenges in M&S will be pointed out to promote discussions on the requirements for improvement with special focus on the comparisons between the available tools and their validations. Sharing of knowledge and experience is now crucial to achieve the ultimate goal of determining optimal M&S approaches to be used in paediatric drug development

Expectations from PK-PD Modelling and Simulation for the Evaluation of Medicinal Products in ChildrenGerard Pons, PDCO, Professor Clinical Pharmacology, Hospital Saint-Vincent de Paul, Service de Pharma, France

Industry Views on the Use of M&S in Paediatric Drug Development Ashley Strougo, Scientist PK Modelling & Simulation, Astellas, The Netherlands

Integration of Modelling into Drug DevelopmentAdam Cohen, Centre for Human Drug Research, Leiden, Netherlands

14:00-15:30 Session 0803

CAN BRIDGING AND EXTRAPOLATION OF DATA REDUCE THE NUMBER OF CLINICAL TRIALS?Session Chair: Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services, Germany

From a regulatory perspective, biomarkers and mathematical functions can be considered as surrogates for bridging efficacy and safety between adults and children or between different paediatric age groups. They must be supported by a robust scientific rationale, and key assumptions must be confirmed by clinical data. Clinical data do not always confirm the original assumptions, and there have been cases where drugs that worked in adults didn’t work at all in children. An additional methodological challenge is the use and limitation of patient reported outcomes in clinical investigations in children.

Bridging between Children and Adults in Paediatric Investigation Plans (PIPs) Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, EU

Expected and Unexpected Clinical Limitations in Bridging from Adults to ChildrenSam Maldonado, Vice President and Head Paediatric Drug Development Center of Excellence, Johnson & Johnson, USA

Information Leveraging: Examining the basis for extrapolationSteven Hirschfeld, Captain, US Public Health Service, Associate Director for Clinical Research, National Institutes of Health, NICHD, USA

Panel Discussion

THEME 8

Theme 8 | Developing Medicines for Special PopulationsAngelika Joos, Director, Head Regulatory Policy, EU and Most of World, Merck Sharp & Dohme (Europe) Inc., BelgiumBirka Lehmann, PDCO, Director and Professor, Head of Licensing Division 3, BfArM, Germany

Regulatory requirements for special populations such as children, pregnant and lactating women and the elderly have received more attention over the past years and many developments are ongoing in this area. This theme will focus on the experience with the Paediatric Scheme and some special aspects related to increased globalisation, pharmacokinetic modelling and simulation as well as extrapolation of data to other populations or age groups with the aim of avoiding unnecessary trials in children. In addition, formulation development has become more important and new formulations that benefit children can also help reducing compliance issues or facilitate adapted dosing for elderly patients. As population ages throughout Europe, regulators and the public have become more concerned with medicine usage and impact of those medicines on elderly and fragile patients who may have underlying concomitant diseases or experience the loss of certain body functions. To address these concerns, clinical research needs to provide better data for those special age groups to inform licensing decisions and post-approval follow-up. Paediatrics, as well as the elderly, are usually multi-drug users and specific risks associated with the use of medicines in those special populations need to be carefully investigated and embedded into the overall risk management strategy of any newly developed compounds. Medicine use during pregnancy


16:00-17:30 Session 0804

RISK MANAGEMENT FOR SPECIAL POPULATIONSSession Chair: Janet Hormbrey, Executive Director and EUQPPV, Merck Sharpe and Dohme, Belgium

The Risk Management Plan as a tool to manage post - authorisation safety risk remains a relatively new tool. However experience is growing in the types of study required to further investigate known or potential risks or missing information, and the kinds of programs that can be utilised in Europe to manage known risks (risk minimisation).There remains little published experience to guide an author of risk management plans, and this is especially so in special populations.Special populations present special challenges and opportunities for the management of risk. Risks in children require attention to effects on long term growth and maturation, the explosion in the number of risk management plans in children and the difficulties of studying this population in long term randomised controlled trials mean that pharmacoepidemiological techniques will increasingly be required.Risk tolerance and the approach to pharmacoepidemiological studies for an NCE in cancer patients depend on the type, incidence and stage of cancer being treated. How best should you approach risk management for a cancer medicine?Risks to the foetus and pregnancy prevention remain perhaps the longest used and best described risk minimisation and management plans. However, substantial problems remain in such programs as they can be costly, restrict patient access and have demonstrated variable success.These evolving topics will be the subject of debate during this session.

Risk Management in Cancer PatientsJoseph H. Hoffman, Global Head, Safety Science Oncology, Safety Risk Management, Roche Pharmaceuticals, USA

Signal Detection in Paediatrics and Use of Observational Data to Assess SafetySandra de Bie, Assessor, Medicines Evaluation Board , The Netherlands

Pregnancy Prevention Programmes to Manage Risks in Fertile WomenIneke Crijns, Senior Clinical Assessor Pharmacovigilance, Medicines Evaluation Board (MEB), The Netherlands

Panel with Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, CDER, FDA, USA


09:00-10:30 Session 0805

CHALLENGES AND OPPORTUNITIES TO DEVELOP SUITABLE FORMULATIONS Session Chair: Gesine Bejeuhr, Senior Manager Regulatory Affairs/Quality, vfa Research-Based Pharm Companies, Germany

The development of a suitable formulation is a thorough scientific process. The active ingredient might for example have characteristics which make it difficult to create an age adapted formulation. Since several excipients should not be used in paediatric formulations the process is even more complex if e.g. taste-masking is needed. At the end only technically high sophisticated formulations might be appropriate for certain age groups. Using these formulations for other patient populations such as e.g. elderly patients might be an option for

a wider use of the required paediatric developments.

Paediatric Formulations – Are they suitable only for children? Practical examplesAgnès Saint-Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU

Medicine Formulation Challenges in Neonatal and Paediatric CareSteve Tomlin, Guy’s and St Thomas’ NHS foundation Trust, Consultant Pharmacist - Children’s Services, Evelina’s Children’s Hospital, UK

Industry Perspective on Formulation Development in Special PopulationsJulie Williams, Executive Director, Pfizer Global Research and Development, UK

11:00-12:30 Session 0806

MEDICINES FOR GERIATRIC PATIENTSSession Chair: Solange Corriol Rohou, Director, Regulatory Affairs, AstraZeneca, France

It is likely that Europe (EU) will face major challenges in relation to population ageing brought about by low fertility levels, improved medical and social care leading to longer life expectancy, and the baby-boom cohorts entering the age of retirement. Ensuring that medicines are labelled appropriately for the elderly is important and this means that they should be included in clinical studies where special ethical, safety and efficacy issues may arise. Information regarding the recent work of the CHMP and the European Medicines Agency in the area of geriatric medicines will be provided.

Elderly Patients: An increasingly relevant patient population Simonetta Alvino, Medical Director, Pharmanet Development Group, Inc., Italy

EMA Geriatric Medicines StrategyFrancesca Cerreta, Scientific Administrator at the European Medicines Agency

Older People’s Needs of Effective and Safe MedicationBarbro Westerholm, Professor Emerita, Member of Swedish Parliament, AGE - Older People`s Platform, Belgium

14:00-15:30 Session 0807/1307

HOW SHOULD THE PAEDIATRIC SCHEME BE AMENDED AND WHY? (JOINT WITH THEME 13)Session Chair: Angelika Joos, Director, Head Regulatory Policy, EU and Most of World, Merck Sharp & Dohme (Europe) Inc., Belgium

The introduction of the Paediatric Regulation was celebrated as important public health milestone in 2006. Its implementation required a significant change in the drug development process and a mindset shift. Experience from industry during the first 3 years of operating under the new scheme will be presented. Concrete changes to current instruments will be suggested to address potential identified short comings in order to ensure that the Regulations’ objectives are effectively met.Reactions and perspectives from policy makers and regulators will complement the picture.

Industry Experience and Main Findings Ali Harrison, Vice President, Regulatory Affairs, AstraZeneca, UK

PDCO Experience and Main FindingsBirka Lehmann, PDCO, Director and Professor, Head of Licensing Division 3, BfArM, Germany

THEME 8 | THEME 9


What Changes Would We Need to Address the Findings?Genevieve Michaux, of Counsel, Covington and Burling, Belgium Panel with Agnès Saint-Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU

16:00-17:30 Session 0808

MEDICINES FOR PREGNANT AND LACTATING WOMENSession Chair: Viveca Odlind, PDCO, Adjunct Professor of Obstetrics and Gynaecology, University of Uppsala; Senior Expert, Medical Products Agency (MPA), Sweden

Medicines usage during pregnancy and lactation is an important public health topic. Integration of animal and human data to assess the risks of the use of medicinal products during pregnancy is a critical task, which is aimed at reducing the induction of birth defects as far as possible. Integration of these assessments is essential for the labelling of a medicinal product. If available, clinical data from exposed breastfed infants should be mentioned together with the conclusions of kinetic studies on the transfer of the active substance into breast milk. This session will also provide some perspective from the practical implications of collecting in use pharmacovigilance data.

Preclinical Aspects of Medicines during Pregnancy Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany

Surveillance of use of Medicines during Pregnancy - The Swedish Medical Birth Registry as an exampleViveca Odlind, PDCO, Adjunct Professor of Obstetrics and Gynaecology, University of Uppsala; Senior Expert, Medical Products Agency (MPA), Sweden

Assessment of Safety of Medicines during BreastfeedingEva Jirsová, Pharmacovigilance Unit, State Institute for Drug Control, Czech Republic

A View from Europe: The IMI EHR4CR InitiativePierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France

A Second European View: The Wellcome Trust Sintero ProjectEd Conley, Co-PI Wellcome Trust Sintero Project, Distributed Collaborative Computing Research Group, Cardiff University School of Computer Science and Informatics, Severnside Alliance for Translational Research (SARTRE), Cardiff & Bristol University Schools of Medicine, Cardiff University, UK

A View from the US: The CDISC healthcare link initiativeLanden Bain, CDISC Liaison with Healthcare, USA

Fergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU

11:00-12:30 Session 0902

NEW APPROACHES TO PHARMACOVIGILANCE WHEN EMPLOYING ELECTRONIC HEALTH RECORDS (EHRS)Session Chair: Sabine Brosch, Business Lead EudraVigilance and International Standardisation in Pharmacovigilance, Pharmacovigilance and Risk Management Sector, European Medicines Agency, EU

With the development of the new ISO Individual Case Safety Reports (ICSR) standard the goal is to achieve a wider interoperability of the information exchange across the regulatory and healthcare communities. Furthermore, the widespread introduction and use of electronic health records provides regulators and researchers with new tools to follow large populations longitudinally for post-marketing surveillance. In this session, the opportunities and challenges of employing EHRs in the area of pharmacovigilance will be examined and explored.

Optimising Adverse Event Reporting with the Electronic Health RecordMarsha Laird, Senior Strategic Analyst, Cerner Corporation, USA

EHR-Driven Safety Surveillance: The death of individual case safety reporting?Ambrish Mathur, Vice President, Strategic Development, Aris Global, USA

Regulatory Initiatives in Support of Pharmacovigilance and EHRsVada Perkins Regulatory Program Management Officer, FDA, USA

14:00-15:30 Session 0903

COMPARING EPRO TECHNOLOGIES: WHAT WORKS?Session Chair: Ingrid Klingmann, Managing Director, Pharmaplex bvba, Belgium

ePRO technology is evolving fast and new techniques are emerging. Web-based PRO data collection has the promise of collecting data directly from the hundreds of millions of patients who have PC- or mobile based access to the web. However, other mobile electronic data capture methods are in broad use as well. How are these methods affecting the way patients participate in clinical trials? How do they feel about using their own computers, mobile phones, digital pens, tablets, and other digital methods to fill in questionnaires? Attendees of this session will learn practical considerations for utilizing different ePRO technologies ranging from PDA and mobile phones to tablet PC’s and the web. Results from tests with people with healthcare or technology background and from cognitive and usability interviews with patients in a real-world setting as well as experiences made in clinical trials will be presented and discussed in this session.

IntroductionRauha Tulku-Wilke, Director Product Management, CRF Health, Finland

THEME 9

Theme 9 | Pharma e-WorldPierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, FranceDavid Iberson-Hurst, CDISC Technical Architect, CDISC, UK

The new pharma world of personalised and translational medicine, with its increasing integration of pharma R&D with healthcare, would not be possible without an ever increasing use of information technologies. This brings a number of drastic changes in processes, standards and tools, as well as the need to deal with the growing concerns of patients about the privacy of their health information. The purpose of this theme is to explore these different topics.


09:00-10:30 Session 0901

USE OF ELECTRONIC HEALTH RECORDS FOR CLINICAL RESEARCHSession Chair: Isabelle de Zegher, Worldwide Senior Director Technology Integration & Data Standards, PAREXEL, Belgium

Linking healthcare and clinical research is a topic we hear a lot about but why do we, as an industry, want to do this, what are the challenges and how close is the reality? In this session we will examine three initiatives, including the Innovative Medicines Initiative (IMI), and explore the key questions, the problems and when we might see production solutions.


11:00-12:30 Session 0906

USING TECHNOLOGY TO IMPROVE THE CLINICAL TRIAL PROCESSSession Chair: Liz Love, Product Manager, Perceptive Informatics, UK

The clinical research industry is steadily moving in the eClinical direction to find efficiencies in their processes. Study start up, randomisation, trial supply management, data collection/monitoring can be managed more effectively by using the right solution. This session will explore and evaluate the key business processes that can be improved by the use of eClinical technology.

Investigator Recruitment – The Role of Technology in Targeting and Selecting Optimal InvestigatorsLiz Love, Product Manager, Perceptive Informatics, UK

Innovative Supply Chain Management – Efficiencies and Cost Reduction in Clinical Trials Chris Wilke, Chief Technology Officer, DATATRAK, USA

Producing Quality Data for Clinical Trials: Is full on-site monitoring the only answer?Imane Kermadi, Director, EMEA, Project Coordination Services, Kendle, UK

14:00-15:30 Session 0707/0907

STATISTICAL COMPUTING: PROGRESS IN COMPUTATIONAL SCIENCE IN CLINICAL TRIALS (JOINT WITH THEME 7)Session Chair: Joachim Vollmar, Executive Consultant, International Clinical Development Consultants LLC, USAOne of the most important and unrecognised issues contributing to drug development time and regulatory quality is the ability to acquire, store, analyse, share and report information needed to make the most informed and rapid decisions in pharmaceutical companies, contract research organisations, and international regulatory agencies. This session will review the current state of data standards, and analytical/graphical tool development, as well as user experiences and expectations

Computational Sciences Initiatives - Improving tools, processes and standards for the statistical review of NDAs and BLAsStephen E. Wilson, Director, Division of Biometrics III, CDER, FDA, USA

Dynamic and Interactive Tools Michael O’Connell, Director, Life Sciences, TIBCO, USA

Graphics Fabrice Bancken, Expert in Quantitative Safety, Novartis Pharma AG, Switzerland

16:00-17:30 Session 0908

CLINICAL TRIAL TECHNOLOGIES AND THE SITE: WHERE NEXT?Session Chair: Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France

Simplicity (for sites) is the Ultimate Sophistication Nikki Dowlman, Product Director, Perceptive Informatics, UK

EDC Achieved: What new challenges did it reveal and what’s next? Simon Brooks, Senior Director Product Strategy, Oracle, UKFergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU

Web-Based Assessments: The internet is an emerging modality in Patient Reported OutcomesBrian Tiplady, Senior Clinical Scientist, invivodata, UKA Scientific Comparison of Mobile Data Capture Technologies Being Used in Clinical Trials: Tablet PC, Keyboard, Personal Digital Assistant and Digital PenRonald Boldt, Lecturer for Process-Oriented IT-Management at HTW-Berlin/Managing Director, Allpen GmbH, Germany

Standardised Evaluation of Patients’ Acceptance of Different ePRO TechnologiesDiane Wild, Director, Oxford Outcomes, UK

16:00-17:30 Session 0904

DATA PRIVACY IN THE PHARMA E-WORLDSession Chair: Anne Bahr, Deputy R&D France Data Privacy Coordinator, sanofi-aventis, France

In recent years medical research and pharmacovigilance have come under the spotlight of several Privacy and Personal Data Protection Authorities. Spectacular lawcourt decisions have raised public attention and new guidances have been issued by several countries that challenge the way we currently run research and drug safety. In this session, we will be addressing these new challenges and providing possible strategies to face them.

Overview of Data Privacy Issues in Biomedical Research Anne Bahr, Deputy R&D France Data Privacy Coordinator, sanofi-aventis, France

Legal Issues Raised by a Research Biobank?Geneviève Michaux, Of Counsel, Covington & Burling, Belgium

Challenges in Dealing with Personal Data Protection in Pharmacovigilance from an EMA PerspectiveSabine Brosch, Business Lead EudraVigilance and International Standardisation in Pharmacovigilance, Pharmacovigilance and Risk Management Sector, European Medicines Agency, EU


09:00-10:30 Session 0905

PRACTICAL IMPLEMENTATION OF THE CDISC STANDARDSSession Chair: David Iberson-Hurst, CDISC Technical Architect, CDISC, UK

Over the past decade CDISC standards became THE reference for clinical research data. However, their implementation can be challenging and this session will propose practical strategies to achieve this goal.

Almost There: CDISC end-to-end using one standards set and one formatJozef Aerts, CEO, Xml4pharma, Germany

From Protocol Design to Final Reporting: CDISC implementationRichard Young, Area Sales Director, Medidata Solutions Worldwide, UK

How to Go Effectively from Data Collection in CDASH to Submission in SDTM: The need for an eCRF libraryIsabelle de Zegher, Worldwide Senior Director Technology Integration & Data Standards, PAREXEL, Belgium

THEME 9



09:00-10:30 Session 1001

THE DEVELOPMENT OF PHARMACEUTICAL PRODUCTS IN THE CONTEXT OF THE NEW QUALITY PARADIGMSession Chair: Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg

This session will cover the latest developments in the New Quality Paradigm impacting the development of drug substances (small molecule and biotech), drug products and how it can facilitate the implementation of new technologies.

Molecules of Chemical Origin in the New Paradigm Keith McDonald, Assessment Team Manager, Licensing Division, MHRA, UK

Biotech in the New ParadigmBrian Withers, Director, CMC Global Pharmaceutical Regulatory Affairs, Abbott Laboratories, UK

Development of New Technology and their Acceptance by RegulatorsAlastair Coupe, Senior Director, Pharmaceutical Sciences, Pfizer Global R&D, UK

11:00-12:30 Session 1002

NEW PARADIGM, LATEST DEVELOPMENT: INTERACTION AND IMPLEMENTATION OF ICH Q8, Q9 AND Q10Session Chair: Georges France, Vice President Quality Strategy, Global Quality Operation, Pfizer, UK

This session will address the achievements of the ICH IWG to achieve consistent, harmonised implementation of Q8, Q9 and Q10, and consider the interaction of these guidelines with the practical implementation of the quality system and new approaches for process validation.An Update on Progress and Achievements of IWG Q8, Q9, Q10 Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg

Quality Systems Following Q10 Principles: Myth or reality?Nigel Hamilton, Quality Director, Sanofi Aventis, France

Process Validation in the New Quality ParadigmFergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU

14:00-15:30 Session 1003

VARIATION REGULATION: POST-APPROVAL CHANGE MANAGEMENT PROTOCOLSession Chair: Keith Pugh, Expert Pharmaceutical Assessor, MHRA, UK

A new variations system was introduced on 1 January 2010 (EC/1234/2008). The accompanying classification guideline introduces the concept of a post-approval change management protocol and addresses how updates in association with agreed protocols will be managed. The protocol is intended to help facilitate the management of post-approval changes to the quality aspects of the dossier, relating to both the active substance and finished product and is not restricted to variations. The session will clarify the principles and procedures related to this new concept as well as reflecting on the potential benefits in terms of simplification and flexibility and any experience to date.

Post-Approval Change Management Protocols – a regulatory perspectiveKeith Pugh, Expert Pharmaceutical Assessor, MHRA, UK

Post-Approval Change Management Protocols - Industry perspective for small molecules Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK

Post-Approval Change Management Protocols - Industry perspective for biological products Brendan Hughes, Vice President, Manufacturing Science and Technology, BioManufacturing Services Group, Pfizer, USA

16:00-17:30 Session 1004

IS THERE A NEED FOR A PHARMACOPOEIA IN THE NEW QUALITY PARADIGM?Session Chair: Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), EU

The “new quality paradigm” outlined in ICH guidelines Q8, Q9 and Q10 offers additional flexibility to companies, e.g. in defining a design space and their control strategy, based on sound and in-depth development studies. The session will discuss the implications this new paradigm has on the pharmacopoeia – a compilation of legally binding quality standards - and will provide the viewpoint of EU regulators, the innovative and the generic industry and the pharmacopoeia on the future role of the pharmacopoeia in this new environment.

A Regulator’s Expectations of the Pharmacopoeia in the New Quality ParadigmKeith McDonald, Assessment Team Manager, Licensing Division, MHRA, UK

How can the Pharmacopoeia Fulfill the Innovator’s Needs in the New Quality Paradigm?Graham Cook, Senior Director, Process Knowledge/Quality by Design Europe, Pfizer, UK

THEME 10 | THEME 11

Theme 10 | CMC, Inspection and Assessment, Quality and CounterfeitingGeorges France, Vice President Quality Strategy, Global Quality Operation, Pfizer, UKJean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg

This theme will address several different areas concerning the pharmaceutical quality of medicines. The latest developments in the new quality paradigm described by ICH Q8, Q9 and Q10, for drug substance and drug product will be discussed, focusing on the practical aspects and including the role of the pharmacopoeia. Opportunities available to the MA holder from combining good pharmaceutical development and quality risk management with an efficient quality system will be considered (e.g. post-approval change management protocols and the Variations Regulation). The theme will also explore the impact on quality and counterfeiting challenge arising from globalisation of pharmaceutical manufacturing and supply chains, and the recent European legislation concerning the development of paediatric medicines. Finally there will be an opportunity for participants to bring their own topics to the forum for debate.


The Role of the Pharmacopoeia in the New Quality ParadigmSusanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), EU

Implications of the New Quality Paradigm for the Generics Industry: A need for the pharmacopoeia to change?Hanno Binder, Global Quality Assurance, Head Quality Systems & Training, Sandoz, Austria


09:00-10:30 Session 1005

GLOBALISATION OF MEDICINE (1): IMPACT ON QUALITYSession Chair: Jacques Morenas, Deputy Director, Afssaps, France

This session will cover how globalisation will impact the quality of medicines, how European authorities will address this with the specific example of Swissmedic. The question of the impact of foreign inspections will be exposed based on the important EFPIA survey and the experience of the industry.

Anti-Counterfeit Strategy of Swiss AuthoritiesRuth Mosimann, Head of Control Illegal Medicines, Swissmedic, Switzerland

How Can We Balance Value, Effort and Risk in Foreign GMP Inspections? A future perspectiveGerd Fischer, Quality Manager, Boehinger-Ingelheim GmbH, Germany

How the Supply Chain will Approach Quality Facing GlobalisationFrédéric Bourgeois, Associate Vice President, Global Quality Supply Chain, Sanofi Winthrop Industrie, France

11:00-12:30 Session 1006

GLOBALISATION OF MEDICINE (2): COUNTERFEITING ASPECTS Session Chair: Thierry Bourquin, Chief Quality Officer, sanofi-aventis, France

This session will cover how falsification impacts the quality of medicine all along the supply chain, how the industry is prepared to cover this important issue, the importance of the industrial audit, including the RX 360 initiative and the major regulator initiative driven by EDQM/Council of Europe.

How industry is Prepared to Address Counterfeiting and FalsificationPaul Heiden, Senior Vice President Compliance, Bayer HealthCare AG, Germany

Industrial Audits and the Rx360 InitiativeAl Kentrup, Vice-Chair Rx360, Pfizer Inc. USA

EDQM/Council of Europe initiative: MEDICRIME convention, API fingerprinting, Track and trace system pilot projectFrançois-Xavier Lery, Department for biological Standardisation, European Directorate for the Quality of Medicines and Healthcare (EDQM), EU

14:00-15:30 Session 1007

PAEDIATRIC FORMULATIONSSession Chair: Diana van Riet, Coordinator, Regulatory Affairs, National Institute for Public Health and the Environment, The Netherlands This session is dedicated to the coming EU guideline on the pharmaceutical development of medicines for paediatric use. The session will provide an in-depth review of the current approaches towards fundamental aspects as the selection of the dosage form, the safety of excipients and patient acceptance, both from a European, WHO and US perspective. It will also update the audience on the latest achievements towards these aspects as achieved by EUPFI, a consortium of EU industry and academia. The European Quality Guideline on Paediatric Formulations Diana van Riet, Coordinator, Regulatory Affairs, National Institute for Public Health and the Environment, The Netherlands

A Global Perspective on the Pharmaceutical Development of Paediatric Medicines Emma Du Four, Director, Regulatory Policy & Intelligence, Abbott Laboratories, UK

Fostering Knowledge on Paediatric Formulation Development: An update from EUPFI Jörg Breitkreutz, Professor for Pharmaceutical Technology, Heinrich-Heine-University Düsseldorf, Institute of Pharmaceutics and Biopharmaceutics, Germany

16:00-17:30 Session 1008

WHAT’S NEW IN QUALITY? (WITH QUESTIONS FROM THE AUDIENCE)Session Chair: Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UKThis session will provide an update of the key quality initiatives in EU, and will reflect the higher priority topics and activities of both the CHMP Quality Working Party and the EFPIA Technical Development Operations Committee.

The following topics are foreseen, but may be revised due to future developments:• process validation/continuous verification• real time release testing • quality of investigational medicinal products • genotoxic Impurities• impact of implementing ICH Q8, Q9 and Q10 on existing guidelines e.g.

specifications • innovative technologies• topics to be proposed by participants.

This will be a joint presentation, providing both an industry and EU regulatory agency perspective. It is envisaged that this will be an interactive session, and audience participation will be actively encouraged. Additional topics from the delegates can be proposed prior to the session.

EU Regulator’s Point of View Diana van Riet, Coordinator, Regulatory Affairs, National Institute for Public Health and the Environment, The Netherlands

Industry Point of ViewMichael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK

THEME 11


Tuesday, 29 March 201109:00-10:30 Session 1101

KEYNOTE INTRODUCTORY SPEECHES SETTING THE SCENESession Chair: Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs and Scientific Communication, Switzerland

In this session keynote speakers from the European Commission, and the device and drug industries will share their views on the pros and cons of the current European legislation for medical devices and drugs. An update on the ongoing recast of the Medical Device Directives will be provided, and the issue of whether changes are needed to the drug and device laws will be discussed.

To What Extent does DG Sanco Anticipate any Elements of Convergence between Drug and Device Regulations in future, and its Reasoning?European Commission speaker invited

The Medical Device Industry View on Drug and Device Regulations ConvergingToni K. Jørgensen, Senior Vice President Corporate Regulatory Affairs, Institut Straumann AG, Switzerland

The Pros and Cons of Drug and Device Regulation Converging - A view from from a company’s perspectiveDetlef Niese, Head Development, External Affairs, Novartis Pharma AG, Switzerland

11:00-12:30 Session 1102

BORDERLINE PRODUCTS AND IMPACT ON DEVELOPMENTSession Chair: Peter Bogaert, Managing Partner, Covington & Burling, Belgium

THEME 11 | THEME 12

This session will give an overview of the European rules and case law on the borderlines between medicinal products and medical devices, explain the main differences between the legal regimes including the pros and cons of each qualification and give practical guidance for applying the rules based on specific cases.

Borderline becomes Border AreaErik Vollebregt, Attorney, Greenberg Traurig, The Netherlands

Medicine – Medical Device Borderline SituationsDavid Van Passel, Senior Legal Counsel, Johnson and Johnson, The Netherlands

Medicine or Medical Device: What legal consequences?Heike Wachenhausen, Head Legal and Regulatory Affairs, Novartis Pharma AG, Switzerland

14:00-15:30 Session 1103

REGULATORY FRAMEWORK FOR COMBINATION PRODUCTSSession Chair: Michael Hotze, Director, Head of Clinical Research, Institut Straumann AG, Switzerland

In this session speakers from industry, a Notified Body and an independent expert will give an overview of the legal framework and the consultation process of the regulatory pathways for registration of drug-device combination products in the US and Europe. In a case study it will be presented how a combination product has been registered globally.

Overview of Legal Framework for Combination Products in the EU and the US Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs and Scientific Communication, Switzerland

Consultation Process for Combination Products – Best practicesGert Bos, Head of Regulatory and Clinical Affairs, BSI, UK

Case Study about Global Regulatory Pathway for Registration of a Combination ProductBernard Sweeney, Executive Director Medical Devices and Country Manager Switzerland, Premier Research Group Ltd, Switzerland

16:00-17:30 Session 0104/1104

IN VITRO DIAGNOSTIC (JOINT WITH THEME 1)Session Chair: Mark Hope, Head of Program Management, F. Hoffmann-La Roche AG, Switzerland

Personalised healthcare and drug-diagnostic combination approaches to treatment have become an important focus over the last few years. This session will discuss what is needed to develop a drug and diagnostic approach, including specific considerations for the development of diagnostic approaches for use of point of care diagnostics within a clinical trial and the path to regulatory approval for a drug-diagnostic combination.

Case Study: Development of an IVDStephen Little, Vice President, Personalised Healthcare, Qiagen, UK

Point of Care Testing in Clinical Trials Mike Wickham, Managing Director, Woodley Equipment Company Ltd., UK

Case Study of Regulatory Process of Registration of In Vitro Diagnostic with a Medicinal ProductMark Hope, Head of Program Management, F. Hoffmann-La Roche AG, Switzerland

Theme 11 | The Drug/Device Boundary: Is it about to disappear?Michael Hotze, Director, Head of Clinical Research, Institut Straumann AG, SwitzerlandShayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs and Scientific Communication Ltd., Switzerland

The European regulatory requirements for marketing medical devices are fundamentally different from those for medicinal products. In Europe, the new approach underpins the medical devices requirements, meaning the manufacturer takes full responsibility for bringing medtech products to market. This is in contrast with the medicinal product regulations, where the competent authority takes responsibility for approving, and thus allowing, a medicinal product to be marketed.

In areas where medicinal products and medical devices are used in combination, the respective regulations of both have already been adapted to address these products. In addition, more lately, the product documentation requirements for medical devices has been increased: for example, the revision of the Medical Device Directive (MDD), which came into force on March 21, 2010, demands more from manufacturers in terms of both the quality and quantity of clinical data. In this track, an overview of the medical device regulations will be given and differences between these and the pharma requirements highlighted. It will also focus on particular topics in the medical device area.

Additional sessions will then address the special situations that arise with medicinal product and medical device combination products, and in vitro diagnostics.



09:00-10:30 Session 1105

POINTS TO CONSIDER IN CLINICAL DEVELOPMENT OF COMBINATION PRODUCTSSession Chair: Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The Netherlands

This session will focus on the development of the clinical program for drug-device combinations. One of the main challenges for the clinical program is to reconcile the requirements of two regulatory systems: the pharmaceutical and the medical device regulatory system. This session will provide some background and practical experience on how to meet this challenge.

Clinical Design of a Combination Product Edith Hantak, Director Clinical Development, Baxter Innovations GmbH, Austria

Effective Planning of Medical Device vs. Drug Clinical Studies: Key Considerations Molly Blake-Michaels, Director, Clinical Services, ClearTrial, LLC, USA

Insights from FDA International GCP Inspections of Device and Device-Drug Combination Products: Case studies for building high-quality data Janice Soreth, Deputy Director, Europe, OC, FDA, USA; Liaison to European Medicines Agency

11:00-12:30 Session 1106

THE DEVELOPMENT OF MEDICAL DEVICESSession Chair: Amanda Maxwell, Manager, SFL Regulatory Affairs Consulting, UK

This session will have an introduction to the work of the Global Harmonisation Task Force and the International Conference on Harmonisation, an overview of the device development process and a summary of how to combine device vigilance and pharmacovigilance responsibilities within one company.

Introduction to the Global Harmonisation Task Force and Comparison with the International Conference on Harmonisation (ICH)Amanda Maxwell, Manager, SFL Regulatory Affairs Consulting, UK

The Development Process for Medical Devices Neil R. Armstrong, CEO, MeddiQuest Limited, UK

Quality System Requirements for a Medical Device CompanyDirk Wetzel, Head of the Medical Devices Division, BfArM, Germany

14:00-15:30 Session 1107

CLINICAL DEVELOPMENT OF MEDICAL DEVICESSession Chair: Danielle Giroud, Founder, World Medical Device Organisation, Switzerland

Many changes have occurred in the past year concerning requirements of clinical evaluation including investigations in Europe but also worldwide. The European Directives have been updated in March 2010 and since several new guidance documents (MEDDEV) have been published to provide additional guidance and clarifications on how the new requirements of the Directives need to be implemented. On an international level, ISO 14155: clinical investigations of medical devices on human subjects, has undergone significant re-writing going much more in depth on the GCP requirements for medical device clinical investigations. GHTF (Global Harmonisation Task

THEME 12

Theme 12 | Drug Development in the Real WorldPhilippa Smit-Marshall, Vice President Medical and Scientific Affairs, PharmaNet B.V., The NetherlandsIneke Rijnhout, Consultant, Kenko International, The Netherlands

This theme will address current issues in global drug development that face innovators and licensees. Have the recent changes in the industry structure with recent mergers and divestment of unwanted drug portfolios had an effect on strategies adopted to get products to market? Moreover, new regulatory challenges and revisions require not only compliance with requirements but also long term post marketing commitments and demand innovative approaches to the global approval process. Achieving quality and effective clinical study conduct determines product competitiveness. Tactics to improve operational achievements, partnering with service providers and the utilisation of emerging territories to recruit sufficient patients on time will be discussed. The increasing influence of patients or patient organisations in clinical research is a phenomenon that will be addressed.


09:00-10:30 Session 1201

EFFECTIVE GLOBAL CLINICAL DEVELOPMENT: FUTURE TRENDSSession Chair: Philippa Smit-Marshall, Vice President Medical and Scientific Affairs, PharmaNet B.V., The Netherlands

This session focuses on some of the current drivers for drug development including the economics of the pharmaceutical industry and clinical disease state modelling. Techniques used to derive information on the most appropriate strategy for conducting clinical research such as data mining techniques will be covered to indicate some of the more innovative techniques to ensure clinical development success.

Quality by Design and the Science of Personalised MedicineDominik Hotz, Director, PricewaterhouseCoopers, Switzerland

Clinical Disease State Modelling: Personalised MedicineMichael N. Liebman, President/Managing Director, Strategic Medicine, Inc. USA

Force) is giving the lead in writing additional guidance documents with regards to post market clinical data requirements. This session will provide an insight in the practical implementation and experienced gained from the implementation of the clinical evaluation requirements in the updated Medical Device Directives and related guidance documents. You will further learn how close to, but yet still distinctively different, ICH 6 requirements are to the updated ISO 14155 and why clinical investigations with medical devices have their specific requirements with regards to the study design and overall study management. The overview will be given both from an industry and regulatory perspective including an update on notified body expectations with regards to clinical evaluation of medical devices.

Clinical Aspects of Latest Version of the EU Medical Device Directives MDD 93/42/EEC and Related Guidance Documents Danielle Giroud, Founder, World Medical Device Organisation, Switzerland

Navigating ICH E6 GCP or ISO 14155 for your Combination Product Matthew J. Tarosky, Acting Director, Division of Bioresearch Monitoring, Office of Compliance, FDA, USA

Notified Body Expectations for Clinical Evaluation of Medical DevicesChristian Schübel, Head Clinical Affairs, TüV Süd Product Service GmbH, Germany


Enlightened Patient: Pharma customer expectations in the 2010s Juha-Matti Saario, SOP Governance Officer, Novartis Pharma AG, Switzerland

Moving Beyond the Agency Interaction: Involving patients in drug development Anders Blaedel Lassen, Reg. Int. & Pol. Specialist, H. Lundbeck, Denmark

Patient PerspectiveMaria Mavris, Drug Development Programme Manager, EURORDIS, France


09:00-10:30 Session 1205

PARTNERING IN DRUG DEVELOPMENTSession Chair: Ineke Rijnhout, Consultant, Kenko International, The NetherlandsNearly half of today’s top-selling drugs in the pharmaceutical industry are the result of partnerships. The pressure to maintain strong portfolios underscores the importance of alliance management. Last year, in the depths of the financial crisis, many companies took drastic restructuring measures, bringing focus and creativity to the efficiency-related challenges. The key driver for survival is their ability to find ways to operate drug development more effectively. What creative partnering structures approaches are companies using in today’s challenging times?

A New Model for Developing CRO Partnership: Project NemoFrederic Monnot, Clinical Research Manager, Merck Serono, Switzerland

CRO Pharma Partnership ExampleSpeaker invited

Biotech/Pharma PartneringSpeaker invited

14:00-15:30 Session 1207

HEALTH ORGANISATIONS AND THEIR INFLUENCE ON DRUG DEVELOPMENTSession Chair: Richard Laing, Team Leader, Medicine Information and Evidence for Policy, Department of Essential Medicines and Pharmaceutical Policies, WHO, Switzerland

Health Organisations play an important role in identifying the health needs of the global population and are instrumental in defining development strategies and access to safe medicines. One such organisation is the WHO. Other important areas are neglected diseases and orphan indications, where financial considerations and the logistical aspects of conducting clinical research in these populations may be important hurdles and play an important role in setting development priorities. The emergence of herbal medicines as a therapeutic intervention is increasing and the appropriate regulation of their manufacture and clinical development will be discussed.

The Role of the WHO in Setting Drug PrioritiesRichard Laing, Team Leader, Medicine Information and Evidence for Policy, Department of Essential Medicines and Pharmaceutical Policies , WHO, Switzerland

THEME 13

Global Trends in Clinical Research – The right indication for the right territory David Cocker, MDC Partners, Belgium

11:00-12:30 Session 1202

COST REDUCTION STRATEGIES IN CLINICAL TRIAL CONDUCTSession Chair: Nermeen Varawalla, Founder & CEO, ECCRO, UK

The imperative to contain the costs of clinical trial conduct is more than ever before. Eliminating the inefficiencies in stakeholder liaison could universally save costs. Best practices in managing CROs, study planning and setting up contracts with clinical trial sites will be shared followed by a discussion of the implementation of these practices.

Cost Reduction during the CRO/Sponsor InterfaceRikke Winther, Divisional Director, Outsourcing Management, H. Lundbeck A/S, Denmark

Reducing Clinical Trial Costs while Maintaining Study achievability: Case studiesMelinda Davis, Director, Clinical Services, Clear Trial, USA

The Impact of Legal and Contract Process on Clinical Trial Costs and Efficiencies Myrthe Rijswijk-Trompert, Independent Consultant, The Netherlands

14:00-15:30 Session 1203

POST-APPROVAL STRATEGIESSession Chair: Jens Reinhold, Head Global Non-Interventional Studies, Bayer Schering Pharma AG, Germany

This session will focus on strategies to maintain product lifecycle and focus on the importance of post-approval research and strategies to ensure rapid approvals to maximise effective patent life on a global basis.

When to Start Thinking about Peri-Approval StrategiesJens Reinhold, Head Global Non-Interventional Studies, Bayer Schering Pharma AG, Germany

Develop Globally - Like it or notNancy Meyerson Hess, Director of Business Development, Harrison Clinical Research, Germany

Managing Lead-Time Reduction for Post -Approval StrategiesLone Eskildsen, Senior Strategic Manager, Novo Nordisk A/S, Denmark 16:00-17:30 Session 1204

PATIENTS: AN INCREASINGLY INFLUENTIAL VOICE IN DRUG DEVELOPMENTSession Chair: Philippa Smit-Marshall, Vice President Medical and Scientific Affairs, PharmaNet B.V., The NetherlandsPatients are important participants in clinical studies and are endpoint users of marketed products with unique expectations. Their voice in how clinical research should be conducted, from their perspective as trial participants, is important and their needs and expectations should be addressed in terms of good clinical practice and setting priorities for medicines development but also in the provision of information on marketed products. Additionally, guardians of vulnerable patient populations such as the elderly and paediatric subjects are instrumental to the success of clinical research and should be active partners in the drug development process.


Neglected Disease and Orphan Medicines Johan Frieling, Consultant, Pharmasquire Consultancy B.V., The Netherlands

The Importance of Herbal Medicines as a Therapeutic Class - How to conduct clinical research and regulate their developmentSpeaker invited

16:00-17:30 Session 1208

INVESTIGATOR-LED CLINICAL DRUG DEVELOPMENTSession Chair: Xavier Carné, Head of Clinical Pharmacology Department, Hospital Clinic, University of Barcelona School of Medicine, Spain

Prior to the introduction of the European Clinical Trial Directive, investigator led clinical development played a prominent role in medicines development. In some settings this is still the case and academic sites regain their influence on defining priorities for medicines based on the latest scientific advances. Speaker from academia and investigator networks will address the challenges ensuring that data generated from investigator led research is of the highest quality and is appropriate to support drug registration.

Investigator-Led Research: Experience of the Medicines for Children Research NetworkNicholas Webb, Royal Manchester Children’s Hospital, UK

THEME 13 | THEME 14

Regulator’s PerspectiveBrigitte Keller-Stanislawski, Head, Pharmacovigilance, Paul-Ehrlich-Institut (PEI), Germany

Public Health Perspective David Salisbury, Director of Immunisation, Department of Health, UK

OMCL PerspectiveSpeaker invited

11:00-12:30 Session 1302HAS THE NEW EU VARIATIONS REGULATION MET ITS OBJECTIVE OF OPTIMISING, SIMPLIFYING AND RATIONALISING THE REGULATORY PROCESSES FOR BIOLOGICALS AND VACCINES? REVIEW OF SPECIFIC EXPERIENCES TO-DATESession Chair:Stephane Callewaert, Senior Manager, Regulatory Policy, Worldwide Vaccine Registration, GlaxoSmithKline Biologicals, Belgium

The new EU Variations Regulation has been driven by the European Commission better regulation initiative, aiming at optimising, simplifying and rationalising the regulatory processes. This session will aim at reviewing/assessing specific experiences to-date of biological products with the key new features introduced.• How helpful is the new variation classification for biologicals? (Type IA “Do

and Tell”, Type IB by default, ...). Are there less Type II for biologicals?• Is the Art.5 recommendation process being used? How is it working so far?

Is there a mindset evolution towards biologicals and vaccines?• Review of experiences of grouping and worksharing. How practical are

these new procedures? Are these applicable and helpful for variations to biologicals and vaccines?

• ‘Quality by Design’ ând ‘Post-Approval Change Management Protocols’: How practical/applicable are such concepts for biologicals? Any experience(s) to date?

Experience and Perspectives of EMAMarie-Hélène Pinheiro, Scientific Administrator, Regulatory Affairs, EMA, EU

Experience and Perspectives of Biotech/Biological CompaniesMerete Schmiegelow, Director Regulatory Intelligence, Novo Nordisk A/S, Denmark

Experience and Perspectives of Vaccine Companies Bertrand Borie, Regulatory Policy & Intelligence Deputy Director Europe, Sanofi Pasteur, France

14:00-15:30 Session 0603/1303

SAFETY ASPECTS IN THE DEVELOPMENT OF VACCINES (JOINT WITH THEME 6)Session Chair: Jan Willem van der Laan, Senior Assessor Section on Safety of Medicines and Teratology Centre, National Institute for Public Health and the Environment (RIVM), The Netherlands

There is an increasing awareness that vaccines have their own characteristics in safety aspects. The recent introduction of adjuvants in marketed products has underlined this. The risk of an increase in autoimmune phenomena and the safe use of vaccines during pregnancy are hot topics. The WHO is giving its perspective on the use of adjuvants.

WHO Perspective on Adjuvants in VaccinesMartin Howell Friede, Technical Officer, Initiative for Vaccine Research, WHO, Switzerland

Investigator Initiated Trials (IIT) – State of the industry and the need for global standards and metrics Ran Frenkel, CEO, Pharma Focus, Israel

Theme 13 | Biologicals and Vaccines – Access to InnovationThomas Verstraeten, Head Biologicals Clinical Safety & Pharmacovigilance, GlaxoSmithKline Biologicals, BelgiumMichael Pfleiderer, Head of Section, Viral Vaccines, Paul-Erhlich-Institut (PEI), Germany

This theme will focus on a number of areas specific to biologicals and vaccines. As well as looking to see what impact recent changes to the EU legislation have had, this theme will provide time to discuss and share new developments and advances that have and will be seen in the area of biologicals and vaccines. And finally, perhaps a slight departure from the other topics under

this theme, there will be a session to allow reflection on the public perception of medicine and in particular the public perception of vaccines and vaccination programmes.


09:00-10:30 Session 1301

PHARMACOVIGILANCE FOR BIOLOGICALS AND VACCINESSession Chair: Phil Bryan, Expert Scientific Assessor, MHRA, UK

This session will outline recent examples of potential quality issues for authorised vaccines, describe the systems in place to identify and evaluate the potential clinical implications and risks and to discuss processes for traceability, recall and implications for immunisation programmes. It will also aim to explore ways in which systems and processes can be improved to optimise risk management of vaccines in this context.


Adjuvants and the Potential Risk of AutoimmunitySarah Gould, Non Clinical Safety Division, Sanofi Pasteur, France

Vaccines and PregnancyJan Willem van der Laan, Senior Assessor Section on Safety of Medicines and Teratology Centre, National Institute for Public Health and the Environment (RIVM), The Netherlands

16:00-17:30 Session 1304SPECIFICITIES OF CLINICAL TRIALS FOR BIOLOGICALS AND VACCINES IN EMERGING MARKETSSession Chair:Emer Cooke, International Liaison Officer, European Medicines Agency, EU

As the dynamics of healthcare environment change, with more emphasis on global access to medicine, there is increasingly a need to undertake clinical research on a global scale. This can be facilitated by increasing harmonisation of process and approach but how can this be achieved?This session will aim to: • Provide an update on ongoing GCP collaboration initiatives and a Regulator’s approach to the globalisation of research• Examine a case study of a company’s experience with outsourcing and off-shoring

GCP – Overview of EMA’s Reflection Paper Fergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU

Specific Considerations for Clinical Trials Conducted Outside the EUHarald Enzmann, Director and Professor, Head of Licensing Division 2, BfArM, Germany

Globalisation, Outsourcing and Off-Shoring in the Context of Resourcing Strategy: Case studyYves Tellier, Head of Data Management, GSK Biologicals, Belgium


09:00-10:30 Session 1305

PROGRESS OF NEW TECHNOLOGIESSession Chair: Bruce Weniger, Associate Editor, Vaccine, Retired/Guest Researcher, U.S. Centers for Disease Control and Prevention , USA

Novel methods in antigen discovery, synthesis, carriage, adjuvantation, and delivery are energising the vaccine segment of the pharmaceutical industry, often with application to mainstream pharmaceuticals. This session will highlight a few of these, including the critical issue of evaluating their safety. Included will be techniques for identifying improved antigens, a regulatory perspective on nanoparticles, new adjuvants to boost the immune response, and needle-free methods for safer, simpler, swifter vaccination.

Old Antigens in New Clothing: Improving on DiscoveryAlan Shaw, CEO and Chairman, VaxInnate Inc., USA

Evaluating the Safety of Nanotechnology for BiologicalsMaria Isaac, Scientific Administrator, European Medicines Agency, EU

Progress in New Adjuvants/ImmunopotentiatorsNathalie Garçon, Vice President and Head Global Adjuvants and Alternative Delivery Centre, GlaxoSmithKline Biologicals, Belgium

Update on Novel Delivery Technologies for VaccinesBruce Weniger, Former Lead, Vaccine Technology at Centers for Disease Control and Prevention, USA

11:00-12:30 Session 1306

INTERNATIONAL COLLABORATION WITH REGARD TO THE REGULATION OF BIOLOGICALS AND VACCINESSession Chair: Pieter Neels, Co-Chair, Vaccines Working Party, CHMP member for Federal Agency for Medicinal and Health Products, Belgium

European Medicines Agency ViewMarie-Helene Pinheiro, Scientific Administrator, Regulatory Affairs, European Medicines Agency, EU

In recent years there has been an increasing recognition of the European Union’s role globally, particularly in the developing world. This session will reflect on the current processes for ensuring availability of products in the developing world, with an update on WHO’s Pre-Qualification Process. This will be combined with a presentation on the ‘Article 58’ procedure, which was introduced in the EU regulatory framework as a way of facilitating patient access to medicines in the developing world. The presentations will be followed by a look at what the EU’s role outside its borders could be in the future

Pre-Qualification Process UpdateWHO speaker confirmed

Article 58 Process Marie-Helene Pinheiro, Scientific Administrator, Regulatory Affairs, European Medicines Agency, EU

Industry Experience of the Pre-Qualification ProcessThierry Gastineau, Senior Director Regulatory Affairs, Sanofi Pasteur, France

14:00-15:30 Session 0807/1307

HOW SHOULD THE PAEDIATRIC SCHEME BE AMENDED AND WHY? (JOINT WITH THEME 8)Session Chair: Angelika Joos, Director, Head Regulatory Policy, EU & Most of World, Merck Sharp & Dohme (Europe) Inc., Belgium

The introduction of the Paediatric Regulation was celebrated as important public health milestone in 2006. Its implementation required a significant change in the drug development process and a mindset shift. Experience from industry during the first 3 years of operating under the new scheme will be presented. Concrete changes to current instruments will be suggested to address potential identified short comings in order to ensure that the Regulations’ objectives are effectively met. Reactions and perspectives from policy makers and regulators will complement the picture.

Industry Experience and Main Findings Ali Harrison, Vice President, Regulatory Affairs, AstraZeneca, UK

PDCO Experience and Main FindingsBirka Lehmann, PDCO, Director and Professor, Head of Licensing Division 3, BfArM, Germany

What Changes Would We Need to Address the Findings?Genevieve Michaux, of Counsel, Covington and Burling, Belgium

Panel with Agnès Saint-Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU

THEME 14


Standards to support work in pharmaceutical development are being developed at global, regional and national levels. After a brief introduction to set the scene, this session will provide information about three standardisation projects and how they will help support the goals of industry and regulators.

Individual Case Safety Reports (ISCR): Progress on the development of the new ISO standardAnja van Haren, EurdraVigilance Coordinator, Medicines Evaluation Board (MEB), The Netherlands

Identification of Medicinal Products (IDMP): Progress on the development of the ISO standardSabine Brosch, Business Lead EudraVigilance and International Standardisation in Pharmacovigilance, Pharmacovigilance and Risk Management Sector, European Medicines Agency, EU

CDISC SHARE – Sharing a better understanding of clinical data David Iberson-Hurst, CDISC Technical Architect, CDISC, UK

11:00-12:30 Session 1402

IMPLEMENTATION OF ELECTRONIC PRODUCT INFORMATION IN THE EUSession Chair: Timothy Buxton, Head of Sector, ICT Development, European Medicines Agency, EU

The session will set out the current position and outline the next steps within the PIM project to brief delegates for planning purposes. Product information in the context of the implementation of the new pharmacovigilance legislation will be considered. The perspective of a National Competent Authority in terms of practical implementation and lessons learned will be presented. These will be complemented by a view on the preparation for the submission of electronic product information in the context of improving readability and consistency across a product family.

Harmonisation Efforts in Connection with Recent EU Renewals to Prepare for Product Information Management (PIM), Improve Readability and Consistency across a Product Family Maja Nordholm, Regulatory Professional, Novo Nordisk A/S, Denmark

Implementing PIM within a National Competent AuthorityKlaus Menges, Head of Unit Scientific Quality Assurance and Process Organisation, BfArM, Germany

PIM: Current Status and Immediate PlanningTimothy Buxton, Head of Sector, ICT Development, European Medicines Agency, EU

14:00-15:30 Session 1403

BEST PRACTICE IN ELECTRONIC INFORMATION EXCHANGE FOR REGULATORY SUBMISSIONS: A ROUNDTABLE DISCUSSIONSession Chair: Remco Munnik, Regulatory Affairs Information Manager, Sandoz B.V., The Netherlands

This session provides an overview of the general vision on electronic submission within Europe and outlines the key developments on specific topics of electronic submission. An update on experience with eCTD, development and implementation of the central gateway, electronic application form is provided by key persons involved in the discussions. Both the current status and future plans that will affect the daily regulatory work, will be presented and discussed.

THEME 14 | THEME 15

16:00-17:30 Session 1308

GLOBAL ACCESS TO VACCINESSession Chair: Sian Clayden, Vice President, Government Affairs and Public Policy, GlaxoSmithKline Biologicals, Belgium

The explosion of vaccine development in recent years is impressive. However, as with all medicinal products, there needs to be mechanisms in place to ensure global access to these vaccines. Various groups have a number of different initiatives underway to try and achieve this. During this session we will hear from these groups about their current and future initiatives.

Jean-Marie Okwo-Bele, Director, Immunization, Vaccines and Biologicals Department, WHO, Switzerland

Jon Pearman, Head of AVI (Accelerated Vaccine Introduction), GAVI Alliance, Switzerland

Theme 14 | Knowledge Management and Telematics: Enhancing exchange between industry and regulators and improving support for their decision-making Andrew P. Marr, Director, Director, Marr Consultancy Ltd, UKTimothy Buxton, Head of Sector, ICT Development, European Medicines Agency, EU

It is evident that data and information, if well-managed, have value and are worth investment. From these elements come knowledge and knowledge underpins timely and informed decisions. Data and information can only be transferred, communicated and managed well through the application of standards, technologies and carefully considered and optimised processes. Such a disciplined knowledge-based approach to the development of medical therapies can lead to better decisions within the industry and by its regulators. In turn this leads to evidence-based decisions from informed healthcare practitioners for the benefit of their patients.

The theme will tackle two major challenges. Firstly it will address the strategic direction within the regulatory and regulated communities and the impact of changes in the legislation and guidance. The implementation of the regulatory EU Telematics Strategy and its application within pharmaceutical industry will be explored through the practical examination of standards, safety analysis and electronic submissions including those for product information. Case studies will contribute powerfully to a detailed understanding of the issues involved. Secondly, the theme will explore the implementation of good knowledge management practices, both in terms of behaviours and technology. Through the value added by standards, technology and processes, effective data, information and knowledge transfer between organisations can be enhanced, ensuring reliability, accuracy, reproducibility, completeness, traceability, timeliness and most importantly, that it is fit for purpose for all stakeholders.


09:00-10:30 Session 1401

STANDARDISATION: HOW IT REALLY HELPSSession Chair: Geoff Williams, e-Regulatory Liaison, Regulatory Operations, Roche Products, UK

The effort to create global standards has been recognised as a key component in allowing industry and regulatory authorities to work more efficiently.


Leigh Sandwell, Associate Director, eBusiness, Pfizer Ltd., UK

Geoff Williams, e-Regulatory Liaison, Regulatory Operations, Roche Products, UK

Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria

Timothy Buxton, Head of Sector, ICT Development, European Medicines Agency, EU

Andrew P. Marr, Director, Global eRegulatory Development, Global Regulatory Operations, GlaxoSmithKline, UK

Andrew P. Marr, Director, Director, Marr Consultancy Ltd, UK

16:00-17:30 Session 1404

STRATEGIC DIRECTIONS IN INFORMATION TECHNOLOGY ACROSS THE MEDICINES NETWORKSession Chair: Katy Page, Senior Director, Worldwide Regulatory Operations, Pfizer, UK

This session will offer several perspectives on the strategic direction for telematics related to electronic submissions and exchange of information across the Medicines Network. An industry overview of US priorities will be followed by a regulator perspective on the status of convergence of technology and approach across Europe. It will conclude with an explanation of the future e-submission standard Regulated Product Standards (RPS), and how this evolution aligns with US and European strategy.

Strategic Directions in the US: An industry perspectiveJohn Kiser, Senior Director, Global Submission Operations & Business Strategy, Global Pharmaceutical Regulatory Affairs, Abbott Laboratories, USA

‘E’ Strategy & the European Submissions Platform: A regulator perspectiveAlison Davis, Director, Information Management Division, MHRA, UK

Regulated Product Standards and Alignment with European StrategyGeoff Williams, E-Regulatory Liaison, Roche Products Ltd, UK


09:00-10:30 Session 0205/1405

IMPLEMENTATION OF THE REVISED VARIATIONS REGULATION – ARE THE OBJECTIVES BEING MET? (JOINT WITH THEME 2)Session Chair: Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK

The revised Variations Regulation (EC No. 1234/2008) applied from 1st January 2010 to marketed authorisations granted through a mutual recognition process, decentralised procedure or centralised procedure. The overall objectives of this revision were to provide a simpler, clearer and more flexible legislative framework governing variations.

Based on 15 months experience, industry and regulatory experts will provide a perspective on whether these objectives are being met. Specific considerations will be given to experience on procedural aspects, managing CMC changes, and implications for e-Submissions.

The Revised Variations Regulation - Are the new ideas at life? Peter Bachmann, Senior Expert, European Drug and Regulatory Affairs, BfArM, Germany

Implementation of the Updated EU Variation Regulation – Simpler, clearer and more flexible? Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, Denmark

Challenges and Opportunities for E-submissionsRemco Munnik, Regulatory Affairs Information Manager, Sandoz, B.V., The Netherlands

11:00-12:30 Session 1406

KNOWLEDGE MANAGEMENT: CULTURES, BEHAVIOURS AND ORGANISATIONSSession Chair: Raun S. Kupiec, Senior Director, Regulatory Affairs, Genzyme Europe, The Netherlands

New standards, technology solutions and process initiatives are everywhere in pharma and the health sector. These initiatives promise to fundamentally alter the way we do business, improving quality and efficiency.

However, dramatic initiatives and fundamental changes are nothing new (remember the paperless office that was around the corner 20 years ago?).

How far have we come, where are we going, and what are the day-to-day implications for how we work in the organisational framework of drug development?

Clinical Trial Registries – Where do we stand? Susanne Jena, Project manager, University Medical Center Freiburg, Germany

Clinical Documentation Made Easy: Managing our eTMF using the DIA reference modelChet Shemanski, Director of Product Management, Nextdocs Corporation, USA

System Validation: Is it fit for purpose?John Wise, Executive Director, The Pistoia Alliance, UK

14:00-15:30 Session 1407

SIGNAL DETECTION – MAKING USE OF AVAILABLE DATA SOURCES Session Chair: Wayne Kubick, Senior Director Product Strategy, Oracle, USA

This session will explain and explore the use of signal detection methods to improve the management of lifecycle product safety. The session will begin with a brief description of signal detection methods, and comprise case studies that discuss signal detection, management and evaluation using spontaneous report and observational data from the perspectives of a sponsor, regulatory authority and academic research organisation.

Implementing Signal Detection Methodology in a Medium-Sized Company: Case studies review William Smedley, Director, PV Operations, Shire Pharmaceuticals, USA

Signal Detection and Management from a Regulatory PerspectivePeter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU

Signal Generation and Evaluation in Health Care Data – A case study using German claims dataMarc Suling, Research Associate, University of Bremen, Bremen Institute for Prevention Research and Social Medicine (BIPS), Germany

THEME 15 | HOT TOPICS | STAND ALONE SESSIONS



09:00-10:30 Session 1501

REGULATION SYSTEMS IN TURKEYSession Chair: Ahmet Araman, Dean, Faculty of Pharmacy, University of Istanbul, Turkey

As an emerging market, the regulation system in Turkey will be discussed.

EU Regulation ComplianceYasemin Karabey, Department Head, EU Regulations, MOH Drug and Pharmacy Directorate, Turkey

Registration ProcessYonca Iscan, Department Head, Bioavailability/Bioequivalence, MOH Drug and Pharmacy Directorate, Turkey

Pharmaceutical Industry and Country Specific ConditionsMelek Bostanci Onol, DRA Manager, Boehringer Ingelheim Ilac Ticaret A.S., Turkey

11:00-12:30 Session 1502

CLINICAL TRIALS IN THE MIDDLE EAST Session Chair: Kathrin Laubacher, Team Leader Training, F. Hoffmann - La Roche AG, Switzerland

In this session you will hear different perspectives on clinical trials preformed in the Middle East. Where do we stand? Which countries do have a law in place? Can we do clinical trials there yet? You will learn about issues and challenges and how to overcome them in this particular region. Excellence versus ChallengesLaila Ghazi Jarrar, Director General, JFDA, Jordan

Globalisation of Clinical Trials: Role of the Middle East Vladimir Misik, Senior Regional Director, Middle East Clin Ops, Quintiles, Austria

Experience with Regulators in the RegionHeba Hashem, Gambro, Egypt

14:00-15:30 Session 1503

JAPANESE REGULATORY SESSION: PMDA UPDATE - INITIATIVES AND CHALLENGES FOR PROMOTING GLOBAL DRUG DEVELOPMENTSession Chair: Kyoichi Tadano, Director, Division of Planning and Coordination, PMDA, Japan

In this session, you will hear a detailed review of the past year at PMDA as well as an overview of initiatives, milestones and current trends for the next year. You will hear directly from senior-level PMDA representatives on issues that may significantly affect your organisation’s regulatory operations

Future Directions and Challenges of PMDA Tatsuya Kondo, Chief Executive, PMDA, Japan

Current Status of New Drug Reviews and Challenges to Promote Global Drug DevelopmentHideo Utsumi, Executive Director and Director, Center for Product Evaluation, PMDA, Japan

Current Projects for Promoting Global Drug Development including JapanYoshiaki Uyama, Review Director, Office of New Drug III, PMDA, Japan

16:00-17:30 Session 1504

CLINICAL TRIALS IN AFRICASession Chair: Jennifer Kealy, Managing Director, Cascade Clinical Consulting Ltd., France

Conducting clinical trials in Africa poses a unique set of challenges, often under extreme conditions (geo-political, lack of regulatory framework, limited infrastructure). Where do you begin? How do you build capacity, identify and manage risks, particularly when it comes to informed consent of illiterate populations? In this session we will address some of the logistical and operational considerations and feature an open panel discussion. Conduct of a Phase III Study in RDC and Liberia: From the Ground UpAnnette Kuesel, Project Manager, WHO/TDR Special Programme for Research and Trianing in Tropical Diseases, WHO, Switzerland

The Challenge to Build Clinical Research Capacity in Africa Gabriele Pohlig, Clinical Research Scientist, Department of Medicines Research, Swiss Tropical and Public Health Institute, Switzerland

Risk Management for Clinical Studies in Africa: Focus on Illiteracy ChallengeEmmanuelle Reau, Senior Manager Quality & Risk Management, Emerging Markets Africa and Middle East, GSK Biologicals, Belgium

HOT TOPICS | STAND ALONE SESSIONS

Theme 15 | Pharmaceutical Development: Regional Perspectives Urszula Scieszko-Fic, Registration Director, Temapharm Sp. z.o.o., PolandVincenzo Cannizzaro, International Regulatory Specialist, Qualitecfarma, Spain

This theme will look at the opportunities within several regions of the world and help attendees understand what challenges these regions are facing. The Japanese Regulatory session which has been an extremely popular and valued session at the EuroMeeting for a number of years will be included in Theme 15.

16:00-17:30 Session 1408

KNOWLEDGE MANAGEMENT: TECHNOLOGIESSession Chair: John Wise, Executive Director, The Pistoia Alliance, UK

In the new global, IT-based knowledge economy, the possession of relevant and strategic knowledge and its unceasing renewal is fundamental for businesses to remain competitive. This session will provide real-world examples of companies successfully tackling this challenge as well as providing a glimpse into how state-of-the-art cloud computing might transform knowledge management in Clinical R&D.

Using Social Media to Support Knowledge Sharing and Obtain Cost Savings - From strategy to action by understanding the users Speaker invited

Knowledge Management Enablers - Operational and quality control centresSiegfried Schmitt, Principal Consultant, PAREXEL, UK

Cloud Computing in Clinical Research & Development – Hype or opportunity?David A. Medina, Director, Worldwide Life Science & Pharma Segment Executive, Hewlett Packard Company, USA



09:00-10:30 Session 1505

GLOBAL SIMULTANEOUS DRUG DEVELOPMENT AND GLOBALISATION OF DRUG DEVELOPMENT: FOCUSING ON CHINA Session Chair: Laurence Huang, Executive Director, Regulatory Affairs, AstraZeneca Pharmaceutical Co., Ltd, China

Over the past few years, multinational pharmaceutical companies are increasingly implementing the strategy of global simultaneous drug development including China. At the same time, the globalization of drug development activities has significantly facilitated the growth of R&D services in China. In this session, speakers will discuss the recent development in drug research, regulation, and clinical trials China in this emerging environment.

CDE UpdateSFDA speaker invited

Preclinical DevelopmentKewen Jin, General Manager, Charles River Laboratories Great China Preclinical Services, China

Clinical Trials and GCP Implementation in ChinaSFDA speaker invited

11:00-12:30 Session 1506

EASTERN EUROPE AND RUSSIA: CURRENT PICTURE AND FUTURE PROMISING PERSPECTIVES OF PHARMACEUTICAL DRUG DEVELOPMENTSession Chair: Urszula Scieszko-Fic, Regulatory Affairs Director, Temapharm Sp. z. o.o., Poland

In 2004 ten new European countries joined the European Union. Currently the biggest country in EuroAsia, Russia, has started deep and challenging reforms in the pharma market. This session will show to the audience the current CEE region trends, the Russian big step forward in drug discovery, opportunities for big and smaller players in this exciting region.

Changes in the Russian Pharmaceutical Market Following Introduction of 2020 Governmental ReformsBeatrice Shepherd, Director CEE Russia & CIS, Frost & Sullivan, Russia

Ukraine: Unknown facts about known countryAndrei Kravchenko, Head of Office, Harrison Clinical Research, Ukraine

Russian Pharma Industry: Opportunities and challengesTatiana Nikolenko, Director of Life Science Programmes, RUSNANO, Russia 14:00-15:30 Session 1507

LATIN AMERICA REGULATORY SESSION: AN UPDATE OF THE PAN AMERICAN NETWORK ON DRUG REGULATORY HARMONISATION (PANDRH) IN LATIN AMERICA - INITIATIVES AND CURRENT DEVELOPMENTS OF REGIONAL COUNTRIES (ARGENTINA, BRAZIL, PERU, MEXICO, OTHERS) ON IMPLEMENTING REGULATORY HARMONISATIONSession Chair: Sergio Guerrero, Director, OCA Hospital/Monterrey Intl Research Center, Mexico

Emerging markets, such as Latin America, are now significant players in the global pharmaceutical industry; therefore current developments have been developed that the region can present attractive new markets and potential research and developments for Latin America. In this session you

will be provided with an update of the initiative of the Pan American Health Organisation related to the forum established through the Pan American Network on Drug Regulatory Harmonisation (PANDRH) to better understand the common regulatory system of the Latin American countries that will promote the harmonisation of the health of the region by facilitating the availability of safe, effective, and quality drugs, and by strengthen the regulatory structure in Latin America that will allow the development of harmonised instruments that can be applicable to all Latin America regional countries.

Representatives from participating countries will present their views and current harmonisation developments in their respective countries. On the other hand, we will discuss future developments of the harmonisation process in other regional countries.

Eduardo Johnson, Manager, Office of Clinical Trials and Bioethics, Institute of Public Health (ISPCH), Chile

Martha Parra Diaz, Committee of New Molecules, COFEPRIS, Mexico

16:00-17:30 Session 1508

TRANSFORMING INDIAN REGULATORY ENVIRONMENT AND ITS IMPACT ON CLINICAL DEVELOPMENT Session Chair: Larisa Nagra Singh, General Manager and Director, Voisin Consulting Life Sciences, India

This session will discuss the evolution of regulatory practices in India over the last 15 years and the impact of the regulatory changes on drug discovery and clinical research practice. The session will also cover the pharmacovigilance reporting practices in India and the readiness of the clinical trial sites to take on more complex protocols.

Evolution of Clinical Research Capabilities in India Across Key Therapeutic Areas Mubarak Naqvi, Director, Clinical Study unit, sanofi-aventis, India

Reporting Requirements per Schedule ’Y'Moin Don, Associate Director (Asia Pacific), Pharmacovigilance QA, Johnson & Johnson – PRD, India

Stem Cell Regulations in IndiaRadhika Bobba, Director/Partner, Anhvita BioPharma Consulting Pct Ltd, India

Hot Topics/Stand Alone Sessions

Tuesday, 29 March 201109:00-10:30 Session 1601

INTERNATIONAL COOPERATION PART 1: STATUS REPORTS ON THE INTERNATIONAL COOPERATION AMONG REGULATORY AGENCIES – FDA, EUROPEAN MEDICINES AGENCY AND PMDASession Chair:Marie Dray, President, International Regulatory Affairs Group LLC, USASince 2004, Confidential Arrangements for Exchange of Information between the US FDA and the European Union (EU) /European Medicines Agency (EMA) and the Transatlantic Dialogue/Administrative Simplification initiatives (2008) encouraged dialogue and exchange of guidances and staff between these regulators. In the interest of transparency, DIA has hosted sessions on plans for, and implementation of formal cooperation among regulators, where senior executives from the FDA, EMA and, most recently, the Japanese PMDA

THEME 15 | HOT TOPICS | STAND ALONE SESSIONS


have very candidly shared their experiences. This session continues this high level conversation with DIA’s audience about these interagency meetings and relationships.

Report from the FDAMurray Lumpkin, Deputy Commissioner for International and Special Programs, FDA, USA

Report from the European Medicines AgencyEmer Cooke, International Liaison Officer, European Medicines Agency, EU

Report from the Japanese Pharmaceutical and Medical Devices AgencyTatsuya Kondo, Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

11:00-12:30 Session 1602

THE STRATEGY OF THE HEADS OF MEDICINES AGENCIES 2011-2015Session Chair: Kent Woods, Chief Executive Officer, MHRA, UK

This session describes the five year strategy of the Heads of Medicines Agencies group, published in November 2010. Individual presentations will consider the main priorities of the strategy and how it is intended that they should be achieved. They will be followed by a panel discussion.

Chairman's Introduction and Overview Kent Woods, Chief executive officer, MHRA, UK Supporting Public Health by the Continuing Improvement of Pharmacovigilance in the EUJytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark

Supporting Industry by Operating Efficient and Accessible MRP/DCPAginus Kalis, Executive Director, Medicines Evaluation Board (MEB), The Netherlands Making Full Use of IT for the Work of the European Medicines Regulatory NetworkMarcus Muellner, Director, AGES PharmMed, Austria

14:00-15:30 Session 1603

THE ROADMAP TO 2015Session Chair: Noel Wathion, Head of Patient Health Protection, European Medicines Agency, EU

On 26 January 2010, the European Medicines Agency published a draft paper setting out its vision for the strategic development of the Agency for the five years to 2015. Building on the progress of its previous five-year strategy, the Road Map to 2015 charts the way forward for the Agency amid rapid developments in medical science and pharmaceutical research, as well as the continuing evolution of the European and international regulatory environments. With this strategy paper to guide it, the Agency will seek to consolidate its achievements to date and further strengthen its role as a guardian of human and animal health in the European Union.

EMA's Roadmap to 2015 - the final versionNoel Wathion, Head of Patient Health Protection, European Medicines Agency, EU

Industry as a Key StakeholderSpeaker invited

From Vision to Reality: Key issues and challenges Emer Cooke, International Liaison Officer, European Medicines Agency, EU

16:00-17:30 Session 1604

INTERNATIONAL COOPERATION AMONG PART 2: REPORT ON INTERNATIONAL COOPERATION – FROM THE POINT OF VIEW OF REGULATORS ON EXCHANGE ASSIGNMENTS Session Chair Brenton James, Consultant in Strategic Regulatory Affairs in the European Union, UK

In this session the regulatory agency staff on exchange will describe their contribution to both agencies. They will speak of policy subjects, development of guidelines as well as therapeutic topics that have been discussed under the Confidentiality Agreements, in the furtherance of Public Health. For the FDA and EMA the role and function of clusters of therapeutic areas to the assessment of applications will be highlighted.

Janice Soreth, Deputy Director, Europe, OC, FDA, USA; Liaison to European Medicines Agency

Hilde Boone, Liaison Official at the FDA, Office of International Programs, European Medicines Agency, EU

Yoshikazu Hayashi, MHLW/PMDA Liaison, Office of Executive Director, European Medicines Agency, EU

18:00-19:30 Session 1900

SWISS SATELLITE SESSION: COOPERATION BETWEEN SWISSMEDIC AND WHO Session Co-Chairs:Petra Doerr, Head of Management Services & Networking, Swissmedic, Switzerland

Lembit Rägo, Coordinator, Quality Assurance and Safety: Medicines, Essential Medicines and Pharmaceutical Polices, WHO, Switzerland

Establishing and maintaining a well-functioning network between international organisations like the WHO and Regulatory Authorities is key to address public health issues in a globalised world. This session will elaborate on the potential impact of cooperation between WHO and regulators to the industry. It will also look at how WHO works with regulators in general and in particular with the Swiss Agency for Therapeutic Products, Swissmedic. Finally, we will look at how the cooperation works, what challenges had to be addressed and what the outcome finally was by presenting two practical examples taken from the field of pharmacovigilance and counterfeit drugs.

Introduction: How the WHO works with regulators Lembit Rägo, Coordinator, Quality Assurance and Safety: Medicines, Essential Medicines and Pharmaceutical Polices, WHO, Switzerland

Overview of Cooperation between Swissmedic and the WHO Cordula Landgraf, Head of Networking, Swissmedic, Switzerland

Real-time Pharmacovigilance: The development of Paniflow Pia Caduff-Janosa, Head Unit Vigilance, Swissmedic, SwitzerlandRudolf Stoller, Head of Division Safety Medicines, Swissmedic, Switzerland



Counterfeit Drugs: The way forward Karoline Mathys Badertscher, Head of Sector Market Surveillance, Swissmedic, Switzerland


09:00-12:30 Session 1605/1606

GCP FORUM: THE CHALLENGES FOR REGULATORS AND SPONSORS WHEN DEALING WITH CLINICAL TRIALS IN A GLOBAL SETTINGSession Co-Chairs: Gabriele Schwarz, Head, GCP Inspection Services, BfArM, GermanyBeat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, Switzerland

The number of clinical trials involving sites and patients outside of, or in addition to the “traditional” Western European and North American research areas, and submitted to drug agencies in different regions for marketing authorisation has been increasing for a number of years. To deal with this challenge the European Medicines Agency (EMA) as well as the US Food and Drug Administration (FDA) have started several activities to establish an international network of clinical trial regulators. The objectives of the network are to promote capacity building, information exchange and cooperation.EMA and FDA launched a joint initiative to collaborate on international GCP inspection activities, which started with an 18-month pilot phase on 1 September 2009. The initiative appreciably contributes to a mutual understanding of the GCP inspection processes utilised in the EU/EEA and US and to a sharing of best-practice knowledge.

In parallel to this strengthened collaboration between Health Authorities that not only leads to a more harmonised approach to inspections but also to a closer supervision through inspections sponsor companies embark on larger trials, move trial activities to “new territories” and engage in all kind of formal and not so formal collaborations (licensing agreements, supported trials, etc.). This requires a much more structured approach to quality and compliance that goes beyond the traditional monitoring and auditing. Quality and hence GCP compliance in a mega-trial, for instance, can only be ensured if the right checks and balances are built into the protocol design and study program as the result of a collaborative efforts of all stakeholders concerned.

This session will provide an up-date of the current harmonisation efforts of Health Authorities and also insight on how a “quality by design” approach to clinical development can allow sponsors, investigators and regulators to address the current unsatisfactory outcomes of today’s approach to quality and compliance.

FDA's International Collaborative Activities to Exchange Scientific, Regulatory and Ethical Information in the Conduct of Clinical TrialsCynthia Kleppinger, Medical Officer, Division of Scientific Investigations, Office of Compliance, CDER FDA, USA

International Cooperation on GCP and Ethical Requirements for Clinical Trials - Current EMA activitiesFergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, EU

International Clinical Trials – Current Afssaps activitiesPierre-Henri Bertoye, Inspectorate and Companies Associate Director, Afssaps, France

Risk-Based Quality Management in Clinical Trials- A European regulator’s view Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany

CRO ViewMartial Verschoot, Executive Director Global External Customers QA, Quintiles, UK

14:00-15:30 Session 1607

INITIATING QUALITY ASSURANCE PROGRAMMES IN WHO-TDR PROJECTSSession Chair :Juntra Karbwang Laothavorn, Clinical Coordinator, TDR, WHO, Switzerland

The session will provide an overview of achievements in clinical research programmes in neglected therapeutic areas to ensure patient safety and deliver quality results when conducting clinical trials in regions with limited exposure to GCP compliance and how other stakeholders, including commercial sponsors, can learn and benefit from such experiences.

Addressing Challenges in Setting-up a Clinical Monitoring System in Developing CountriesChristine Halleux , Technical officer, TDR, WHO, Switzerland

Addressing Challenges in Fostering an Ethical Review System in Developing CountriesCristina Torres, FERCAP Coordinator, FERCAP, Thailand

Developing Quality Assurance for Laboratories Used in Clinical ResearchMichael Mihut, Quality Management, TDR, WHO, Switzerland

Collaboration between TDR and EMA for Better Human Subject ProtectionMarie-Helene Pinheiro, Scientific Administrator, Regulatory Affairs, European Medicines Agency, EU

16:00-17:30 Session 1608

ENCEPPSession Chair :Noël Wathion, Head of Public Health Protection, European Medicines Agency, EU

Three years after the ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilancewas initiated by the EMA, this collaborative project with European pharmacoepidemiology researchers has delivered a code of conduct for transparency and indepedence in commisioned research, a checklist on important methodological standards for study protocols, a public database of European research resources and a public database of post-authorisation studies. These developments will facilitate the conduct of high quality, multi-centre, independent post-authorisation research in the form of "ENCePP studies". With the first request to conduct an ENCePP study received by EMA in Spetember 2010, this session will discuss the current status of ENCePP, the significance of ENCePP studies, expectations form different stakeholders and planned future developments.

ENCePP: Where we are and highlights for 2011 Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU

Importance of ENCePP to Academia and the Challenges Ahead Corinne de Vries, Professor of Pharmacoepidemiology, University of Bath, UK Industry Perspective on the Role of ENCePPValerie Simmons, EU QPPV Executive, Global Patient Safety, Eli Lilly and Company Ltd., UK




09:00-10:30 Session 1701

MANAGING THE INNOVATION: FROM APPROPRIATENESS TO SUSTAINABILITY FOR NATIONAL HEALTH SYSTEMS - ON FIELD EXPERIENCES IN THE ITALIAN CONTEXTSession Chair :Carlo Tomino, Director, Research and Clinical Trials Unit, Italian Medicines Agency, Italy

The early phases of marketing represent the most delicate period of the new drugs’ lifecycle. This is especially stressed in the case of innovative drugs because of the partiality of information related to efficacy, safety and applicability when used in the common clinical practice. This session is intended to show how the Italian Medicines Agency (AIFA) works, since 2005, using telematic treatments registers in order to define the correct place in therapy of monitorised new products, the drug’s risk management plans and the sustainability for national health systems (NHS).

Managing and Monitoring the Appropriate Use of Innovative Therapies through Healthcare Web-Networks: A challenge to support the clinical practiceEntela Xoxi, Pharmacologist Advisor, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy

The Risk-Sharing Approach in Marketing Authorisation: Regulatory and operating aspects introduced by the Italian Medicines Agency via the Innovative Cancer Drugs RegisterLuca De Nigro, Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy

The Potential of Post-Marketing Monitoring in Benefit/Risk AssessmentEnrico Bosone, Director, Regulatory Affairs and Compliance, Celgene Italy, Italy

11:00-12:30 Session 1702

HOW WILL THE PHARMACEUTICAL PACKAGE IMPACT DAY-TO-DAY PHARMACOVIGILANCE OPERATIONS?Session Chair :Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany

The Pharmaceutical Package will change the existing pharmacovigilance systems with respect to documentation, roles and responsibilities and many workflows such as ICSR transmission, PASS, PSUR etc. Since the intent of the new legislation is harmonisation and simplification, it is important that this intent will not get lost during the translation of the law into the detailed guidance. The speakers will elaborate on the areas which require further attention and provide recommendations. The session will also encourage an early dialogue of the stakeholders involved.

Practical Implications of the PPP on Pharmacovigilance ActivitiesMargaret Walters, Director, EU PV and DQPPV, Merck, Sharpe and Dome Ltd., UK

Key Issues for the Expected Implementation Measures and GPVP GuidanceChristine Bendall, Consultant, Arnold and Porter Solicitors, UK

Implication for Regulatory AgenciesDolores Montero, Head of the Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Medicines Agency, Spain

16:00-17:30 Session 1704

ASSESSING THE ADDED VALUE OF MEDICINES: RECONCILING THE NEEDS OF PAYERS, PATIENTS AND INNOVATORS Session Chair:Richard Bergström, Director-General, LIF Sweden Patients expect to get the best medicine to meet their individual needs. Pharmaceutical companies expect that patients will have access to the new medicines that the industry develops. Payers must however also meet budget targets and may need to prioritise between medicines. It is widely accepted that payers should not only look for the lowest price per pill, bur rather assess the value to patients, health care and society at large. Such an assessment must compare new medicines to existing ones, while taking into account that patients are different and will need alternatives treatments. For the research-based industry it is also important to retain incentives for development of break-through medicines as well as product that bring incremental added value to certain patients.

Putting the Patient at the Centre: Moving from words to action Mary Baker, MBE, President, European Federation of Neurological Associations, Belgium. President of European Brain Council, EU How to Balance Innovation and Solidarity Lieven Annemans, Health Economist- Pharmacoeconomist, University of Gent, Belgium Learning from US Healthcare Reform and CER: Reconciling different objectives Cliff Goodman, Vice President, The Lewin Group, USA Panel debate with Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU and Andrea Rappagliosi, Vice President European Government Affairs & Head of Brussels Office, GlaxoSmithKline, Belgium


49

New at the EuroMeeting


12:45-13:45

THE SPIDR QUIZ(Statistical Principles in Drug Regulation)

How familiar are you with statistical principles in clinical trials? Want to deepen your understanding and/or test out your knowledge alongside fellow volunteer team members in a fun-packed quiz? Would you like to help your team to win the overall prize?

Facilitator: Kerry Gordon, Executive Director, Biostatistics, Quintiles Ltd., UKStatistics is an integral component of drug development, as enshrined in the ICH E6 Guideline on Good Clinical Practice and further elaborated in ICH E9 Statistical Principles for Clinical Trials. The need to be au fait with these principles is ever-present throughout the design, set-up, conduct, analysis and reporting of clinical trials, and not just among the statistical community. So, if you are not a statistician, or maybe you are a statistician but want to refresh your skills (or simply show them off!), why not join us, as this hugely popular quiz comes to the DIA Euromeeting? To register your interest …

LUNCHTIME BRIEFINGSMake the most of your time at the EuroMeeting – even at lunchtime. DIA Europe is running three Lunchtime Briefings at the EuroMeeting 2011 for the first time. Taking place between 13:00 and 13:30, they are perfect for the busy attendee with a packed agenda. Don’t forget to join us for lunch on the Exhibition Floor either before or after the Briefing.


13:00-13:30

DO WE NEED PHARMACEUTICAL MEDICINE?Jean-Paul Deslypere, CEO, Aesculape Pte Ltd., Singapore

Although Pharmaceutical Medicine has been introduced more than 3 decades ago, it is still not widely recognised. Common sense dictates that drug development should only be conducted by specialised personnel but on the other hand the training, certification and specialisation possibilities are still limited. This session wants to explore the reasons for this duality and also present new initiatives in the field.

13:00-13:30

THE DEVELOPMENT SAFETY UPDATE REPORTBarry Arnold, EU Qualified Person for Pharmacovigilance, AstraZeneca, UK

The ICH E2F guideline (Development Safety Update Reports) reached step IV in August 2010. Implementation is ongoing in Europe, such that DSURs will be mandatory for all annual safety reports for investigational products from September 2011 onwards. This presentation will review the rationale for ICH E2F, provide an overview of the ICH E2F guideline and consider the practical implications of its implementation during 2011.


13:00-13:30

SUPPORTING PATIENT READINESS AND ADHERENCE THROUGH PATIENT-CENTRED COMMUNICATION Wolf Langewitz, Professor, Institute for Psychosomatic Medicine, University Hospital Basel, Switzerland

Starting antiretroviral treatment and maintaining lifelong adherence is challenging for both patients and healthcare providers in HIV treatment. We developed an algorithm for health care providers (HCP) to guide patients in the situation of treatment start. In a second step, we developed a workshop teaching HCP on implementing the algorithm and how to improve patient centred communication skills. The session will introduce to the concept and the specific readiness teaching tools

This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.

Benefit from DIA Membership

• Stay Informed

• Build Professional Relationships

• Develop Your Career



EXHIBIT AT THE EUROMEETING

E X H I B I T O R SCompany Country

Across Systems GmbH Germany

Acurian USA

Advanced Search & Selection / Advanced Regulatory UK

AdWare Research Ltd. Hungary

AKOS Ltd. UK

Almac USA

APCER PHARMA UK

Applied Clinical Trials USA

ArisGlobal Germany

Asia Global Research Co. Ltd. Thailand

Averion International USA

AXESS Ltd. UK

AXPHARMA SAS France

Barrington James Ltd. UK

BaseCon Denmark

BioKinetic Europe Ltd. UK

BioStorage Technologies GmbH Germany

Brillance Sp. z o.o. Poland

Business & Decision Life Sciences Belgium

C3i Inc. Bulgaria

Cardio Analytics UK

Cardiocore USA

Catalent Pharma Solutions UK

CCRA UK

CDISC USA

Celerion USA

CEMO SA France

Chiltern UK

Clinical Professionals UK

Clinical Reference Laboratory UK

clinIT AG Germany

ClinTec International UK

CLS Communication Switzerland

CMIC Co., Ltd. Japan

Comply Services Belgium

CoreLab Partners, Inc. USA

Covance UK

CRF Health USA

CROM Group Italy

CROss ALLIANCE Switzerland

Crown CRO Finland

CTC Clinical Trial Consulting AG Switzerland

dabl Ltd. Ireland

Datatrak International USA

DIA Patient Fellowship Switzerland

Diamond Pharma Services UK

Company Country

Dora Wirth Languages UK

Drug Safety Alliance, Inc. USA

DSG, Inc. USA

eClinica Belgium

ECLINSO AG Switzerland

emedcareers.com UK

ENNOV-CLINSIGHT France

Entimo AG Germany

ePharmaSolutions USA

ERT USA

EUDRAC France

European Medicines Agency EU

Eurotrials Portugal

EXTEDO Germany

FGK Clinical Research GmbH Germany

Geny Research Group, Inc. USA

GFA UK

Glemser Technologies USA

Harlan Laboratories Switzerland

Harrison Clinical Research Germany

Hays Pharma UK

i3 USA

i4i Inc. Canada

Imperial Clinical Research Services USA

INC Research USA

Integrated Clinical Systems, Inc. USA

INTERLAB central lab services - worldwide Germany

INTRALINKS UK

invivodata, inc. USA

Key People Ltd. UK

Keypoint Consultoria Cientifica Portugal

Kinapse UK

Lambda-Plus Belgium

Levy Associates UK

LINDEQ Norway

Lionbridge Life Sciences USA

Liquent, Inc. USA

LORENZ Life Sciences Group Germany

MakroCare India

Mango Solutions UK

MDCPartners Belgium

MedDRA MSSO USA

MEDICADEMY Denmark

Medicines Evaluation Unit UK

Medidata GmbH Germany

Medidata Solutions UK

Exhibiting Companies as of 28 January 2010


E X H I B I T O R SCompany Country

Meditrial Europe Ltd Switzerland

MESM UK

MNX Global Lifesciences Logistics UK

monitoforhire.com USA

NDA Group Sweden

NextDocs USA

NNIT Denmark

Nova Language Services UK

nSpire Health USA

Ocasa Logistics Solutions USA

Octagon Research Solutions Ltd. UK

Omnicare Clinical Research USA

Online Business Applications USA

OpenClinica USA

ORACLE France

Outcome USA

Paragon Biomedical USA

PAREXEL International USA

Perceptive Informatics USA

PFC Pharma Focus Ltd. Switzerland

Pharmaceuticals and Medical Devices Agency (PMDA) Japan

PharmaForms GmbH Germany

Pharmalink Consulting UK

PharmaNet Development Group UK

PharmaVigilant USA

PHASTAR UK

PHT Corporation USA

Popewoodhead & Associates Ltd. UK

PRA International USA

Prime Vigilance Ltd. UK

Product Life France

PRUDENTAS LLC Russia

PSI Switzerland

Quadratek Data Solutions Ltd. Germany

Quality & Compliance Consulting, Inc. USA

QUMAS Ireland

RBW Consulting LLP UK

Real Pharma Germany

Real Regulatory UK

Regulatory Pharma Net Italy

Regulatory Resources Group Ltd. UK

Richmond Pharmacology Ltd. UK

RPS, Inc. USA

RWS Translations UK

Safety Drugs Italy

Schlafender Hase GmbH Germany

Company Country

SDL UK

SEC Pharma UK

Sentrx USA

SGS France

Simbec Research Ltd. UK

Sofus Stockholm Consulting AB Sweden

SRA International USA

Stamford Consultants AG Switzerland

Superior Document India

Swissmedic Switzerland

SYMA

SYMFO International SA France

SYNE QUA NON UK

Synevo Central Lab Poland

Tarius Denmark

TecHorizon Italy

TechTeam Global Belgium

The Regulatory Affairs Company UK

Thomson Reuters USA

TOPRA UK

Transcrip Partners LLP UK

TransPerfect USA

Trifecta Multimedical USA

Trilogy Writing & Consulting Germany

United BioSource Corporation USA

University Hospital Clinical Trial Alliance (UHCT Alliance) Japan

Uppsala Monitoring Centre Sweden

Veeva Systems, Inc. USA

Viedoc Sweden

Virtify, Inc USA

Vitalograph UK

WCI Consulting Limited UK

WellCRO (Brand of Axonal) France

Wiley-Blackwell Germany

Woodley Equipment Company Ltd. UK

XClinical Germany

Exhibiting Companies as of 28 January 2010

52 ABOUT GENEVA

ABOUT GENEVAJoin us in Geneva... Rejoignez-nous à Genève...

About GenevaGeneva has the perfect location – on the banks of Lake Geneva and at the foot of the Alps. Its cosmopolitan flair perfectly reflects the international attendance of the EuroMeeting which attracts participants from over 50 countries. Geneva hosts the European headquarters of the United Nations, the headquarters of the International Red Cross as well as around 20 more major international organisations, 170 NGOs and 200 diplomatic missions. The Jet d’Eau on the lake, one of the world’s tallest water fountains shooting water 140 metres in the air, provides an excellent point of reference. In your free time, explore Geneva’s past in the old town or visit one of the more than 40 museums in the city. Geneva is very much a city of culture. Take a cruise on the lake or stroll through one of the waterfront parks. There is something for everyone. If you are thinking of extending your visit, head for the mountains. In an hour you can be on top of the world – whether to ski or just to enjoy the view and the fresh air.

Geneva has sometimes been described as one of Europe's most unavoidable cities – everybody passes through here at one point thanks to Geneva’s excellent transportation connections. Geneva International Airport links the city with the world, complemented by the excellent high speed train services to Paris, London and Milan as well as its location at the junction of the northern and southern European motorway systems.

Quick FactsLocation: Geneva is located in the south-western corner of Switzerland, on the banks of Lake Geneva Population: The second largest city in Switzerland with an international population of 185,000 Climate: Pleasant all year round due to the soothing effects of the lake and surrounding mountainsCurrency: Swiss FrancLanguage: French, but English is widely spokenHotels: Over 125 quality hotels

Geneva Palexpo is ideally located right next to the international airport with its own underground railway station about 300m away from the arrival and departure levels. Simply leave the Palexpo Convention Centre and check in for your flight. The city centre is only 6 minutes away by train. In a city with a long tradition of high-level meetings, Geneva Palexpo has proved itself to be one of Europe’s most versatile convention centres.

The Convention Centre Getting to Geneva

By planeGeneva International Airport (http://www.gva.ch) links Geneva to a network of approximately one hundred destinations around the world. The Star Alliance member airlines are offering EuroMeeting participants discounts on airfares to Geneva. See page 47 for further details.

By railThe Swiss national rail system (www.rail.ch) has an extensive network across Switzerland with hourly trains running to cities such as Lausanne, Bern, Basel, Zurich and to the popular holiday regions of the cantons of Vaud and Valais. The heart of Paris is only 3 and a half hours away from Geneva by the TGV (high velocity train). Reaching a maximum speed of 270 km/h (170 m/h), city-centre to city-centre travelling time compares very favourably with intercity flights.


53NETWORKING EVENTS

Networking Opportunities

Networking is an integral part of the EuroMeeting. Participants tell us that the networking

opportunities presented by the EuroMeeting are one of the key reasons for attending. Each

year, the EuroMeeting offers numerous opportunities to catch up with existing contacts

and to make new ones in a relaxing setting. All networking events at the EuroMeeting are

included in the registration fee.

La Grande ReceptionMonday, 28 March 2011, 17:30-19:30 at the Ramada Park Hotel

Le Grande Reception is our Monday networking cocktail reception with drinks and snacks

and an excellent opportunity to renew your existing contacts and to make new ones. It is

exclusive to EuroMeeting registered participants. The Ramada Park is a short distance from

the Convention Centre by taxi or by public bus. For your added convenience, there will be

shuttles from outside the Convention Centre to the Ramada Park starting at 17:15.

DIA Special Interest Area Communities (SIACs) – Meet and EatTuesday, 29 March 2011, 12:30-13:15

An opportunity for all SIAC members – and those interested in joining one – to get together

for a networking lunch. DIA Europe’s Volunteer Services Manager will be on hand to answer

any questions.

Speed Networking SessionTuesday, 29 March 2011, 13:30-14:00

The EuroMeeting is used as a networking opportunity by all participants. The EuroMeeting Speed Networking session aims to facilitate conversations

amongst participants.

Speed networking, brings together individuals who are attending a conference. It will help you to make new contacts and intensify your networking

experiences. The goal is to ensure that each participant will make at least six new professional contacts during the speed networking sessions.

Tuesday ReceptionTuesday, 29 March 2011, 17:30-18:30

Tuesday’s networking reception takes place on the exhibition floor. Drinks and snacks are included. It is open to all registered participants.

Network on the Exhibition FloorAll refreshments will be served on the exhibition floor making it the ideal place to meet the people you want to meet. There will be two internet cafés,

attendee lounges and a cash bar situated on the exhibition floor.


54 ACCOMMODATION AND TRANSPORTThis is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.

Special Hotel Rates for your EuroMeeting 2011 Stay in Geneva

DIA Europe has negotiated special conference hotel rates for EuroMeeting participants. Rates will include breakfast, service and all taxes. You will receive a city-wide Geneva Transport Card at check-in which will give you complimentary access to local transport in the city.

Please be advised that DIA Europe has only one contracted and exclusive hotel agent for the EuroMeeting 2011: K.I.T. Group.

DIA Europe works with one agent to ensure that:• Your hotel reservations are officially part of the EuroMeeting• The hotel rates have been individually negotiated for the EuroMeeting and are exclusive to EuroMeeting participants• Your hotel reservations, privacy and personal data are completely secure

Hotel rooms can be booked on the DIA EuroMeeting website. Go to www.diahome.org/euromeeting2011 and click on the EuroMeeting icon. For any questions please contact [email protected].

Receive up to 20% off airfares through the Star Alliance Network!

The Star Alliance™ member airlines are pleased to be appointed as the Official Airline Network for the 23rd Annual EuroMeeting in Geneva.Participating airlines include:

Booking office information can be found at www.staralliance.com/conventionsplus

1. Choose “For Delegates”2. Under “Delegates Login” enter event code SK03A103. Choose one of the participating carriers listed.

Registered participants plus one accompanying person travelling to the event are automatically granted a discount of up to 20%, depending on class of travel. Discounts are offered on most published business and economy class fares, excluding website/internet fares, senior and youth fares, group fares and round-the-world fares.

Free public transportation in GenevaAll visitors staying at a hotel in Geneva will receive a free Geneva Transport Card on check-in which enables complimentary use of the entire Geneva public transport network without restriction (bus, train and boat) with validity for the entire duration of their stay including their departure day.

• ANA • Adria Airways • Austrian Airlines • Blue1 • bmi • Brussels Airlines • Croatia Airlines • Continental Airlines • EgyptAir

• LOT Polish Airlines • Lufthansa • SWISS International Air Lines • Scandinavian Airlines • Spanair • TAP Portugal • Turkish Airlines • United Airlines

Book by 17 December 2010 and be entered to win an Apple iPad.

CliniCal ForuMBasEl 201110-12 October 2011 Congress Center Basel | Basel, Switzerland

5 t h a n n u a l

DIA2011Convergence of Science Medicine, and Health

47th Annual MeetingJune 19-23, 2011

McCormick PlaceChicago, IL

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PROGRAM CHAIR

Kenneth A. Getz, MBA Chairman of CISCRP and Senior Research Fellow at the Tufts Center for the Study of Drug Development

WHAT TO EXPECT AT DIA 2011

DIA 2011 will feature 15 tracks in a variety of formats to provide you with a comprehensive portfolio of educational opportunities and unparalleled skills at every stage of the pharmaceutical value chain by:

• Bringing together industry professionals, clinicians, patient representatives, and regulatory agencies from all continents

• Facilitating knowledge exchange needed to positively impact innovation and ultimately patient care and outcomes

• Building upon DIA’s traditional breadth and depth of topics running the gamut from preclinical research through postmarketing safety and surveillance

• Expanding the discussion of current issues to include new areas such as comparative effectiveness, health outcomes, and medical devices

David D. Ho, MD is the founding Scientific Director and Chief Executive Officer of the Aaron Diamond AIDS Research Center, a world-renowned biomedical research institute. He is also the Irene Diamond Professor at The Rockefeller University.

Dr. Ho has been at the forefront of AIDS research for 29 years, publishing more than 350 papers. His elegant studies, beginning in 1994, unveiled the dynamic nature of HIV replication in vivo and revolutionized our basic understanding of this horrific disease (Nature 1995; Science 1996). This knowledge led Dr. Ho to champion combination antiretroviral therapy (N. Engl. J. Med. 1995; Science 1996) that resulted in unprecedented control of HIV in patients (Nature 1997). AIDS mortality in richer nations has declined 6-fold since 1996, and a massive international effort is now underway to bring such life-saving treatment to millions in the developing world. Dr. Ho has been the major driving force behind this major medical breakthrough in what is arguably the worst plague in human history.

His research team is now devoting considerable efforts to developing vaccines to halt the spread of the AIDS epidemic. Furthermore, he is now heading up a consortium of Chinese and American organizations to help address the crisis of HIV/AIDS in China.

Dr. Ho has received numerous honors and awards, including being named Time Magazine’s Man of the Year in 1996, and the recipient of a Presidential Medal in 2001.

For more information on the 2011 DIA Annual Meeting, visit www.diahome.org.

Time Magazine Man of the Year Will Deliver Keynote Address at DIA 2011

57

Monday, 28 March 2011 Monday, 28 March 2011Pre-Conference Tutorials 09:00 - 12:30 Pre-Conference Tutorials 09:00 - 12:30

Plenary 14:00 - 17:15 Plenary 14:00 - 17:15

La Grande Reception Networking Reception 17:30-19:30 La Grande Reception Networking Reception 17:30-19:30

Theme 1 Theme 2 Theme 3 Theme 4 Theme 5 Theme 6 Theme 7 Theme 8 Theme 9 Theme 10 Theme 11 Theme 12 Theme 13 Theme 14 Theme 15 Theme 16

Innovation, Future of Treatment and

Personalised Medicine

Securing Approvals in a Changing Environment for

the Benefit of Patients

Patient Safety: From Data Collection and Integration to Benefit/Risk Analysis and Risk Minimisation

Clinical Study Endpoints and HTA/Cost Effectiveness

Wider Access (Switching/Generics)

Engaging the Research World! Pre-Clinical

Research and Development

Statistics across the Drug Lifecycle

Developing Medicines for Special Populations

Pharma e-WorldCMC, Inspection and

Assessment, Quality and Counterfeiting

The Drug/Device Boundary: Is It about to

Disappear?

Drug Development in the Real World

Biologicals and Vaccines – Access to Innovation

Knowledge Management and Telematics

Pharmaceutical Development: Regional

Perspectives

Stand-Alone Sessions/Hot Topics

Tuesday, 29 March 2011 Tuesday, 29 March 2011

Session 109:10:30

Session 0101/0701Trial Design and Interpretation

for Personalised Medicine- Delivering C21 Drug Development

Session 0201Evolutions in the EU

Regulatory Landscape

Session 0301Globalisation of Safety:

Pharmacovigilance and Drug Safety in Emerging Asia

Session 0401Update on How Agencies

Assess Therapeutic Value of a Product and – Increasingly – the

Therapeutic Added Value

Session 0501Switching: Is there an ideal route?

Session 0601International Strategy for Non-Clinical Consultants


for Personalised Medicine- Delivering C21 Drug

Development

Session 0801Increasing Global Regulatory

Dialogue

Session 0901Use of Electronic Health

Records for Clinical Research

Session 1001Development of

Pharmaceutical Products in the Context of the New Quality Paradigm

Session 1101Keynote Introduction –

Setting the scene

Session 1201Effective Global Clinical Trial Development: Future Trends

Session 1301Pharmacovigilance for

Biologicals and Vaccines

Session 1401Standardisation:

How it really helps

Session 1501Regulation Systems in Turkey

Session 1601International Cooperation

Among Regulatory Agencies Part 1

Session 1701Managing the Innovation: From appropriateness to

sustainability for NHSs - On field experiences in the Italian

context

Coffee Break Coffee Break

Session 211:00-12:30

Session 0102The Role of Personalised

Medicine in Safety

Session 0202/0302Decision-Making Process of Benefit/Risk Assessment –

A collaborative framework approach



Session 0402Can We Merge Two Different Worlds? Regulatory review

for market authorisation and HTA assessment for reimbursement

decision

Session 0502Are New Switches in Line with the Expectation of the “Empowered

Patient”?

Session 0602Non-Clinical Evaluation of

Drug-Induced Hepatotoxicity

Session 0702Quantitative Approach for

Benefit/Risk – Challenges and Opportunities

Session 0802Will Modelling and Simulation Accelerate Drug Development

for Children?

Session 0902New Approaches to

Pharmacovigilance when Employing Electronic Health

Records (EHRs)

Session 1002New Paradigm, Latest

Development: Interaction and implementation of ICH Q8, Q9

and Q10

Session 1102Borderline Products and Impact on Development

Session 1202Cost Reduction Strategies in

Clinical Trial Conduct

Session 1302Has the New EU Variations

Regulation Met its Objectives of Optimising, Simplifying and Rationalising the Regulatory

Processes for Biologicalsand Vaccines?

Session 1402Product Information

Management (PIM): In production – migration deadline approaching

Session 1502Clinical Trials in the

Middle East

Session 1602The Strategy of the Heads of

Medicines Agencies 2011-2015

Session 1702How will the Pharmaceutical

Package Impact Day-to-Day Pharmacovigilance

Operations?

Lunch Lunch

Session 314:00-15:30

Session 0103Developing Personalised

Medicines – Delivering the diagnostics

Session 0203Strategies to Obtain Competitive

Approvals in a Changing Environment

Session 0303From RMP to REMS: Is a Global Approach to Risk Management

Achievable?

Session 0403Comparison of Endpoints for

Market Authorisation and Reimbursement: How can we

harmonise assessment?

Session 0503Changing Regulatory

Environment: Impact on the self-care sector

Session 0603/1303Safety Aspects in the

Development of Vaccines

Session 0703Recent Developments in Software Solutions for Adaptive Trial Designs

Session 0803Can Bridging and

Extrapolation of Data Reduce the Number

of Clinical Trials?

Session 0903Comparing ePRO

Technologies: What works?

Session 1003Variation Regulation: Post-approval change management protocol

Session 1103Regulatory Framework for

Combination Products

Session 1203Post-Approval Strategies



Session 1403Best Practice in Electronic Information Exchange for Regulatory Submissions

Session 1503Japanese Regulatory Session

Session 1603Roadmap to 2015


Session 416:00-17:30

Session 0104/1104In Vitro Diagnostic

Session 0204Developing Advanced Therapy

Medicinal Products – Challenges and opportunities

Session 0304New Pharmacovigilance

Legislation: Facilitation and transparency

Session 0404Can We Reach Some

Harmonisation among Europe on HTA Review?

Session 0504Is the Patient/Consumer Adequately Informed?

Session 0604Biobanking: Logistics and

samples handling

Session 0704Common Issues at SAWP

(Scientific Advice Working Party)

Session 0804Risk Management for Special Populations

Session 0904Data Privacy in the

Pharma e-World

Session 1004Is There a Need for a

Pharmacopoeia in the New Quality Paradigm?


Session 1204Patients: An increasingly influential voice in drug

development

Session 1304Specificities of Clinical Trials

for Biologicals and Vaccines in Emerging Markets

Session 1404Strategic Directions in

Information Technology across the Medicines Network

Session 1504Clinical Trials in Africa



Session 1704Assessing the Added Value

of Medicines: Reconciling the needs of payers, patients and

innovators

Networking Reception 17:30-18:30 Networking Reception 17:30-18:30

Wednesday, 30 March 2011 Wednesday, 30 March 2011

Session 509:00-10:30

Session 0105How to Pay for Personalised

Medicine? The Value of Stratification

Session 0205/1405 Implementation of the Revised Variations Regulation - Are the

objectives being met?

Session 0305Practical Challenges in Risk

Management

Sesison 0405FDA Guidance on Patient-

Reported Outcomes and the European Medicines Agency’s

Paper on Health- Related Quality of Life

Session 0505Supply of Quality Medicines to

Developing Countries

Session 0605Non-Clinical Aspects of

First-In-Humans

Session 0705Using Indirect Comparisons in Assessment of Clinical Data

Session 0805Challenges and Opportunities

to Develop Suitable Formulations

Session 0905Practical Implementation of

the CDISC Standards

Session 1005Globalisation of Medicine (1):

Impact on Quality

Session 1105Points to Consider in Clinical Development of Combination

Products

Session 1205Partnering in Drug

Development

Session 1305Progress of New Technologies



Session 1505Global Simultaneous

Drug Development and Globalisation of Drug

Development: Focusing on China

Session 1605/1606GCP Forum


Session 611:00-12:30

Session 0106Qualify, Validate, Apply - assuring

assay quality through the biomarker lifecycle

Session 0206Town Hall Meeting -Meet the Regulators

Session 0306Data Sources for

Pharmacovigilance Assessment

Session 0406Assessing Symptoms in Global Clinical Trials to meet FDA and

European Medicines Agency Standards

Session 0506How to Increase Access to

Biosimilar Medicines

Session 0606Biomarkers in Non-Clinical

Safety Assessment

Session 0706Communicating Complex

Statistical Results

Session 0806Medicines for Geriatric Patients

Session 0906Using Technology to Improve

the Clinical Trial Process


Counterfeiting Aspects

Session 1106Development of Medical

Devices

Session 1306Europe’s Role in Supporting the Regulation of Biologicals and Vaccines outside Europe

Session 1406Knowledge Management:

Cultures, behaviours and organisations

Session 1506Eastern Europe and Russia: Current picture and future

promising perspectives of pharmaceutical drug

development


Lunch Lunch

Session 714:00-15:30

Session 0107Clinical Utility and

Implementation -The gatekeeper for successful personalised

medicine

Session 0207Meeting the Information Needs

of the Patient

Session 0307How Better Incident Management

Prevents Crisis

Session 0407Scientific Advice on Endpoints:

To comply or not to comply

Session 0507How to Improve the Current

Regulatory Framework in order to Increase Access to Generic Medicines

Session 0607The Non-Clinical

Development of Anti-Cancer Pharmaceuticals

Session 0707/0907Statistical Computing:

Progress in Computational Science in Clinical Trials

Session 0807/1307How Should the Paediatric

Scheme be Amended and Why?



Session 1007Paediatric Formulation

Session 1107Clinical Development of

Medical Devices

Session 1207Health Organisations and their Influence on Drug

Development



Session 1407Signal Detection – Making use

of available data sources

Session 1507Latin America

Regulatory Session

Session 1607Initiating Quality Assurance Programmes in WHO-TDR

Projects


Session 816:00-17:30

Session 0108Personalised Medicines for

the Real World

Session 0208How to Make the Product Available to the Patient

Session 0308Risk Communication and

Tansparency in the 21st Century: Lessons for pharma

Session 0408Public-Private Partnerships –

Initiatives to reach consensus on patient-reported endpoints

Session 0508Pros and Cons of the Current

Decentralised Procedure Generic Applications

Session 0608Contemporary Issues in

Non-Clinical Development of Biotechnology-Derived

Products

Session 0708Subgroup Analyses

Session 0808Medicines for Pregnant and

Lactating Women

Session 0908Clinical Trial Technologies and

the Site: Where next?

Session 1008What’s New in Quality?

Session 1208Investigator-Led Clinical Drug

Development

Session 1308Global Access to Vaccines


Technologies

Session 1508Transforming Indian

Regulatory Environment and its impact on Clinical

Development

Session 1608ENCePP

End of Conference End of Conference

23RD ANNUAL EUROMEETING AT A GLANCE

58


Plenary 14:00 - 17:15 Plenary 14:00 - 17:15

















Disappear?





Perspectives



Session 109:10:30














Development


Dialogue






Setting the scene





How it really helps






context


Session 211:00-12:30


Medicine in Safety







decision


Patient”?






for Children?



Records (EHRs)



and Q10










Middle East





Operations?

Lunch Lunch

Session 314:00-15:30






Achievable?











of Clinical Trials?













Session 416:00-17:30










samples handling





Pharma e-World





development










innovators



Session 509:00-10:30






Management







First-In-Humans





the CDISC Standards


Impact on Quality


Products


Development









Session 611:00-12:30











Safety Assessment


Statistical Results







Devices






development


Lunch Lunch

Session 714:00-15:30



medicine


of the Patient


Prevents Crisis















Medical Devices


Development






Regulatory Session


Projects


Session 816:00-17:30


the Real World










Products



Lactating Women





Development



Technologies



Development

Session 1608ENCePP



59


Plenary 14:00 - 17:15 Plenary 14:00 - 17:15

















Disappear?





Perspectives



Session 109:10:30














Development


Dialogue






Setting the scene





How it really helps






context


Session 211:00-12:30


Medicine in Safety







decision


Patient”?






for Children?



Records (EHRs)



and Q10










Middle East





Operations?

Lunch Lunch

Session 314:00-15:30






Achievable?











of Clinical Trials?













Session 416:00-17:30










samples handling





Pharma e-World





development










innovators



Session 509:00-10:30






Management







First-In-Humans





the CDISC Standards


Impact on Quality


Products


Development









Session 611:00-12:30











Safety Assessment


Statistical Results







Devices






development


Lunch Lunch

Session 714:00-15:30



medicine


of the Patient


Prevents Crisis















Medical Devices


Development






Regulatory Session


Projects


Session 816:00-17:30


the Real World










Products



Lactating Women





Development



Technologies



Development

Session 1608ENCePP



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