on: • devices emia an medicine 3rd international congress

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To Register T +49 (0)30 20 91 33 30 | F +49 (0)30 20 91 33 12 | E [email protected] | www.paediatrics-congress.com/MM

Integrated PaedIatrIc Drug DevelopmentWriting a PIP • Preparing comprehensive clinical studies • Conducting successful clinical trials

13th – 15th April 2011 | Dorint Hotel Sanssouci Berlin-Potsdam | Germany

3rd international congress

Researched and developed by

Media Partners

Supported by

Hear international case studies from leading companies and institutes:

• Bayer Schering Pharma AG, Germany

• F. Hoffmann-La Roche Ltd., Switzerland

• Almirall R&D, Spain

• Federal Institute for Drugs and Medical Devices, Germany

• Merck Sharp & Dohme Limited, United Kingdom

• Astellas Pharma Global Development Europe, The Netherlands

• Paul-Ehrlich Institute, Germany

• Granzer Regulatory Consulting & Services, Germany

• Omnicare Clinical Research, Germany

• University Children’s Hospital Heidelberg, Germany

• Dutch Patent Office, The Netherlands

• INTERLAB central lab services – worldwide, Germany

• Only for children pharmaceuticals, France

• Novartis Pharma AG, Switzerland

• Medicines and Healthcare products Regulatory Agency, United Kingdom

• Learn how to develop a successful Paediatric programme in line with EMA and FDA requirements

• Benefit from your peers' experiences in successfully translating a PIP into clinical trials to ensure a smooth implementation

• Find out key requirements from pharmacology for the successful implementation of your trials in neonates, infants and children to avoid high failure rates

• Examine the practical challenges from preparing your trials such as toxicology, informed consent and palatable formulations

Visit our download center for free white papers, articles and much more! www.paediatrics-congress.com/MM

"Excellent package of interesting and relevant topics together with well

experienced speakers!"

Dr. Frank Hoffmann, Manager Regulatory Affairs, Grünenthal GmbH

Chairmen:

Dr. Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services

Join our interactive workshops:

A The PIP process – an operative hands-on workshop

B Clinical pharmacology in neonates, infants and children

C Outsourcing the paediatric investigation plan: How to optimise the cooperation in developing the PIP

D Practical considerations in regards to paediatric studies: design, challenges, strategies and operational tips

Learn from these experts amongst others:

Dr. Dirk Mentzer, Head of Pharmacovigilance, Paul-Ehrlich-Institute & PDCO

Dr. Pauline Walstra, Director Regulatory Affairs Development, Astellas Pharma Global Development Europe

Dr. Gonzalo de Miquel, Director Respiratory Therapy Area, Almirall R&D

Dr. Corina Becker, Expert Clinical Pharma-cokinetics, Clinical Pharmacology representative in the BSP Pediatric Task Force, Bayer Schering Pharma AG

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Special case studies on:• Paediatric inhalation devices• Paediatric leukemia• Paediatric organ transplantation medicine

Dr. Bruno Reigner, Senior Clinical Pharmacologist, F. Hoffmann-La Roche Ltd.

CanBiotechR&D Outsourcing

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Register for our email updates!Get the latest news on our events, additional down-load possibilities, early bird deadlines and much more! Register now at www.paediatrics-congress.com/MM.

Congress advisor

Dr. Klaus Rose is a Principal Consultant at Granzer Regulatory Consulting & Services and Former

Head of Paediatrics at Roche Pharmaceuticals, a position which he held until November 2009. He quali-fied in medicine in Berlin and com-pleted his postgraduate clinical training in General Medicine in Germany and England before joining the pharmaceutical industry in 1991. He also serves as chairman to the EFGCP children’s medicines working party.

Dear colleague,

The EU paediatric regulation on Medicinal Products for Paediatric Use of 2007 has dramatically changed the landscape of drug development in Europe.

The industry is facing internal and external challenges regarding the strategic planning and development of the Paediatric Investigation Plans (PIP), the integration of paediatrics into the overall drug development process and issues surrounding the required paediatric clinical trials.

IQPC is providing an intimate opportunity to the professionals in paediatric drug development to update and enhance your knowledge, share experiences and discuss current issues, at our


Integrated PaedIatrIcDrug Development

• Preparing comprehensive clinical studies • Conducting successful clinical trials


Don’t miss this opportunity to discuss the latest developments in paediatric drug development and find answers to the following questions:

• What key factors need to be considered to develop successful Paediatric Investigation Plans that are in line with EMA requirements?

• How can you design a global paediatric programme that complies with both the FDA and EMA regulations to avoid duplication of work?

• What is important when translating a PIP into clinical trials to ensure a smooth implementation of your paediatric studies?

• What are the specific requirements from pharmacology for the successful implementation of your trials in neonates, infants and children to avoid high failure rates?

We are looking forward to meeting you in Potsdam.

Kind regards,

Katrin Bender Your Pharma IQ Team


Integrated PaedIatrIc Drug Development



Who will you meet?

Job functions:Directors, Heads, Group or Section Leaders, Project Managers and Senior Scientists

Industry:Pharmaceutical and biotech companies as well as paediatricians, academic clinicians, patient asso- ciations and regulatory authorities from Europe and beyond

Departments:

• Regulatory Affairs• Clinical Development • Clinical Operations• Clinical Research• Clinical Pharmacology• Pharmaceutical Development• Pharmaceutical Sciences• Paediatrics• Drug Development• Drug Discovery• Drug Safety• Quality Assurance• Preclinical Research• Formulations

Sponsorship

We have a variety of packages available to suit your requirements. For all Sponsorship and Exhibition opportunities call Joanna Golley: +49 (0)30 20 91 32 75 or email [email protected].

Media Partners

Since 72 years, pharmind® has been the periodical to be read by decisionmakers and multipliers of the pharma scene. Taking into consideration the national and international (in particular EU and FDA) regulatory environment, the entire range of issues involving the development, manufacture, and marketing/sales of pharmaceutical products is covered in depth. www.ecv.de

www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals. www.pharmcast.com

INTERLAB is an independent CENTRAL LABORATORY supporting regional, international and global clinical trials for pharmaceutical and biotechnology companies. INTERLAB has developed into a worldwide network covering Europe, North and South America, Australia, Africa and Asia including India and China. Project teams assigned to coordinate study logistics are in Germany and USA. www.INTERLAB.de

CanBiotech – A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharma-ceutical and venture capital directories and databases. Publications include the Bio Outsourcing Asia© Publication. Read about opportunities in India, China, Malaysia, Singapore, Taiwan and more. www.canbiotech.com

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INTERACTIvE WORkSHOP DAy | Wednesday, 13th April 2011



The PIP process – an operative hands-on workshopWorkshop A 10:00 – 13:00

Pharmaceutical companies of any size are faced with the challenge of submitting a realistic and scientifically sound development proposal to the EMA. Within this framework, there are many pitfalls and challenges. Find out which key factors need to be considered and which strategies have been successful to ensure your own PIP will be accepted. This workshop will cover the following subjects:

Dr. Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services, Germany

• Early planning and paediatric homework• Paediatric key opinion leaders: how to find and how to handle • EMA website: forms, deadlines, decisions

• The PIP negotiation procedure • Positive opinion, deferral follow-up reports, compliance certificate• Lessons learnt

• Children’s blood volume is very limited: presentation of special sampling techniques and low-volume analytical methods; practical teamwork• Planning a sound logistical framework by integrating all departments and external partners

Clinical pharmacology in neonates, infants and childrenWorkshop B 10:00 – 13:00

With the EU Paediatric Regulation from 2007 it becomes inevitable to conduct clinical trials with paediatric populations. For these, dosage selection and determination on an optimal balance between clinical efficacy and safety as developed for adults need to be adequately adapted to the specific paediatric population.

The selection of suitable medicines and dosages for use in children however, is far more difficult due to their susceptibility to adverse drug reactions and differences in the maturity of their organs. Therefore, being able to predict the pharmacokinetic parameters in children accurately, especially as these vary in a given population, will increase the efficiency of paediatric clinical trials by developing dosing regimens and sampling times.

This interactive workshop will focus on how pharmacokinetic and pharmacodynamic factors in children of varying ages can effectively be dealt with by discussing:

Dr. Corina Becker, Expert Clinical Pharmacokinetics, Clinical Pharmacology representative in the BSP Pediatric Task Force, Bayer Schering Pharma AG, Germany

• The impact of age on absorption, distribution, metabolism and elimination of medicines in children • Scaling to children using prior information and different modelling approaches • Translation of modelling results in first in paediatric studies

• Difficulties in measuring drug exposure and effects of medicines in children • Aspects that need to be considered for carrying out paediatric Pk/PD studies • Data analysis and bridging to succeeding paediatric studies

Outsourcing the paediatric investigation plan: How to optimise the cooperation in developing the PIP

Workshop C 14:00 – 17:00

The development of a sound strategy for the PIP is a huge additional burden in the drug development process. Many pharmaceuticals and biotech companies do not yet have in-house paediatric expertise and take the opportunity to outsource this process. However, as a successful PIP is essential in the development of a new drug, these partners need to be considered carefully and the cooperation needs to go hand in hand. This workshop will give you a good overview and guideline regarding the key factors that need to be considered when outsourcing your PIP:

For further information visit our website: www.paediatrics-congress.com/MM

• Planning your PIP submission• Which in-house departments should be involved?• Interaction with CRO/writer

• Interaction with PDCO• Key points for successful PIP outsourcing

Dr. Hermann Schulz, Chief Executive Officer, INTERLAB central lab services – worldwide

Dr. Katja Neuer-Etscheidt, Manager, Business Development, INTERLAB central lab services – worldwide

Practical considerations in regards to paediatric studies: design, challenges, strategies and operational tips

Workshop D 14:00 – 17:00

Paediatric clinical trials are significantly more challenging than running studies in adults. Involving children requires a more personal approach with respect to ethical considerations, project planning, blood collection procedures and logistics in general. Legal require-ments are continuously being adapted both in Europe and USA and have to be taken into account when planning multinational or even global clinical trials. This workshop will discuss the practical key points that need to be considered from a strategic and operational point of view:

• Key considerations for the development of a paediatric programme • Strategies to stay within timelines, to ensure smooth implementation and to reduce operational costs• Guidance to a successful cooperation with external partners

Highlight

Highlight

09:00 Registration & Coffee

09:30 Chairman’s welcome & opening address Dr. Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services, Germany

Latest insights into strategic debate on paediatric regulation

09:40 EU Paediatric Regulation – experience with PIPs • General considerations for PIP application to EMA • Addressing medical needs of target population • Significant therapeutic benefit in paediatrics • Pharmacovigilance and risk assessment in paediatrics • Addressing measures in the PIP opinion Dr. Dirk Mentzer, Head of Pharmacovigilance & member of the PDCO, Paul-Ehrlich-Institut, Germany

10:20 Integration of children into the drug development process: An appraisal of the EU Pediatric Regulation in its 5th year • What has the EU Paediatric Regulation achieved so far? • Measurable and not measurable results in competitive and confidential environment • Paediatric Committee – PDCO’s reputation between black box and historical breakthrough • Checks and balances in the EU Paediatric Regulation – Could industry be a partner? • Paediatric drug development worldwide: Consulting between EMA, FDA and MHLW • The way forward Dr. Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services, Germany

11:00 Refreshment break & networking

11:30 Paediatric rewards: Supplementary Protection Certificates (SPC) and data/market exclusivity • Which rewards are available and what do they include? • Timing and requirements for obtaining rewards • Scope of protection: patent versus SPC versus data exclusivity • Strategic considerations when applying for rewards • Relevant recent EU case law on SPC's Dr. Nikki Rethmeier, Senior consultant IP and biotechnology, Dutch Patent Office, The Netherlands

Developing a paediatric programme for EMA/FDA requirements

12:10 key factors for designing a successful PIP • What are the requirements from the PDCO? • What procedural aspects need to be considered? • What are the requirements for referral and waiver? • Which criteria need to be fulfilled for the compliance check? • When is a request for modification needed? Dr. Birka Lehmann, Director and Professor, Head of Licensing Division 3 & member of the PDCO, Federal Institute for Drugs and Medical Devices, Germany

12:50 Networking luncheon

14:20 PIP submissions – an assessor’s view point • Assessment strategy • Key factors to facilitate assessment • Characteristics of good applications • Pitfalls to avoid • Anonymized case studies Dr. Angelika Siapkara, Medical Assessor, Special Population Group, VRMM, Medicines and Healthcare products Regulatory Agency, United kingdom

15:00 Development of a global paediatric development plan: industry insight • What is required from EMA/PDCO and FDA? • How to implement paediatric development in your company to suit regulatory demands? • How can clinical studies being harmonized to suit a global strategy? • Case studies Dr. Pauline Walstra, Director Regulatory Affairs Development, Astellas Pharma Global Development Europe, The Netherlands


16:10 The value of juvenile animal toxicity studies for paediatric drug development • When are juvenile animals studies needed? • Timing, role and use of juvenile animal toxicity studies in the development strategy • Examples on how to design and conduct juvenile animal studies • How predictive are juvenile animals for findings in children Dr. Ciska van Doesum-Wolters, Associate Scientific Director, Translational Toxicology, Astellas Pharma Global Development Europe, The Netherlands

16:50 Panel discussion: Trends to harmonisation: What are the potentials and key issues for a global paediatric programme? • What are the challenges of designing a global programme? • What key factors need to be considered? • What are the trends for a global harmonisation in paediatric regulations and do they make sense? • What is a feasible timeline? Panellists: Selected speakers of the day

17:30 Closing remarks of the chairman

17:35 End of congress day one


CONGRESS DAy ONE | Thursday, 14th April 2011



The Dorint Hotel Sanssouci Berlin-Potsdam invites you to an evening reception. This is an excellent opportunity for you to meet the other attendees and make new business contacts.

Get free white papers, articles and much more! www.paediatrics-congress.com/MM

What’s in your download center?The purpose of the download center is to provide you with relevant content to enhance your knowledge of current trends and industry news. All content is 100% complimen-tary, easy to download, and current. Featuring live podcast interviews which you can stream on your computer or portable device, up-to-date news from local and interna-tional sources, industry whitepapers, and other relevant content – the download center is your online portal to expand your knowledge and add value to your business.We encourage your feedback and participation, for all comments or enquiries please contact Doreen, Hannah or Mark on +49 (0)30 20 91 32 74 or [email protected].

Highlight

Highlight

08:30 Registration & Coffee

09:00 Chairman’s welcome & opening address Dr. Bruno Reigner, Senior Clinical Pharmacologist, F. Hoffmann-La Roche Ltd., Switzerland

Preparing for paediatric trials

09:10 Informed consents from infants and children • Overview over current regulatory framework and ethical guidelines • Common practical and ethical challenges affecting assent • How to design a consent form for different age groups • Experiences in assuring informed consent and working with different age groups Dr. Martine Dehlinger-Kremer, Vice President Global Regulatory Affairs, Omnicare Clinical Research, Germany

09:50 Developing palatable formulations for successful paediatric products • Influence of the formulation and form of/devices for administration on the drug’s success • Preferences of different age groups • Taste masking/taste assessment Dr. Gesine Winzenburg, Fellow, Technical Research& Development, Novartis Pharma AG, Switzerland


11:00 Handling studies for inhalation devices in the paediatric population • Inhalers – A world of confusion? • Inhalation manoeuvres and techniques • Impact of errors and mistakes on treatment’s effectiveness • Examples of handling studies in adults and paediatrics with portable inhalers Dr. Gonzalo de Miquel, Director Respiratory Therapy Area, Almirall R&D, Spain

11:40 Developing specific formulations for neonates • Overview of the existing "guidance" around different routes of administration for different age groups • Challenges of designing suitable formulations/delivery devices for neonates • Intravenous drug delivery as a "suitable" route for neonates? • MSD case study Dr. Richard Kendall, Senior Research Scientist, Merck Sharp & Dohme Limited, United kingdom

12:20 Networking luncheon

Hands-on experiences with paediatric drug development

13:50 Prepare & negotiate the PIP for acute lymphoblastic leukemia indication • The importance of paediatric drug development: O4CP’s model • Outline of the PIP key factors and study outline • Challenges from translating the PIP into practice • Dealing with the practical challenges in paediatric oncological clinical trials Dr. Vincent Grek, President & Medical Director, Only for children pharmaceuticals, France

14:30 Experiences from clinical trials of immunosuppressants for paediatric solid organ transplant recipients • The point in time for trials in the pediatric population • The appropriate design of clinical trials in pediatric patients and adequacy of sample size • Age-related issues within the pediatric age group and appropriate study endpoints • Potential age- and development-related side effects of novel immunosuppressants • Primary EBV infection and EBV-triggered PTLD • The need for-long-term studies • Mechanistic and pharmacokinetic/pharmacogenetic substudies Prof. Dr. med. Burkhard Tönshoff, Professor of Pediatrics and Pediatric Nephrology & Vice Chairman of Paediatrics, University Children’s Hospital Heidelberg, Germany


Clinical pharmacology in pediatric drug development

15:40 Paediatric clinical development plans: A clinical pharmacology perspective • The high failure rate in pediatric confirmatory trials, exploring possible reasons • A two-step model: Exploratory dose finding then confirmatory efficacy/safety trial • Adding the pediatric bridging elements to the two-step model • Pediatric bridging and regulatory guidance/guidelines • Future directions in pediatric drug development, including trial simulations Dr. Bruno Reigner, Senior Clinical Pharmacologist, F. Hoffmann-La Roche Ltd., Switzerland

16:20 How to bridge from adults to children and into a successful paediatric programme • Differences in PK and PD in adults and children • Extrapolation strategies from adults to children • Implementation of M&S based extrapolation into a paediatric clinical trial Dr. Corina Becker, Expert Clinical Pharmacokinetics, Clinical Pharmacology representative in the BSP Pediatric Task Force, Bayer Schering Pharma AG, Germany

17:00 Closing remarks of the chairman

17:10 End of congress day two


CONGRESS DAy TWO | Friday, 15th April 2011



For further information

please visit our website www.paediatrics-congress.com/MM or contact Doreen, Hannah or Mark on +49 (0)30 20 91 32 74 or email [email protected].

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A: The PIP process – an operative hands-on workshopB: Clinical pharmacology in neonates, infants and childrenC: Outsourcing the paediatric investigation plan: How to optimise the cooperation in developing the PIPD: Practical considerations in regards to paediatric studies: design, challenges, strategies and operational tips

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on: • devices emia an medicine 3rd international congress

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