vifor stream 1 - iperion · single submission portal combined cesp/gateway claudia pyne, publishing...

Where Regulatory Affairs professionals meet to share feedback and experiences27-29 October 2015Hotel Palace Berlin | Berlin | Germany

www.GPRAS.com

Sponsors & Exhibitors

Stream 1 Regulatory Affairs in Russia, CIS, Turkey and MENA Latest regulatory updates and industry feedback for successful product registration

Stream 2 Regulatory Affairs in Latin America and Asia-Pacific Navigating the regulatory framework and ensuring best practice for product approval

Stream 3 Global eSubmissions Latest telematics updates, regulatory insight and practical experiences for global eSubmissions

New for 2015

IDMP and RIM Focus

Day

Expert Speakers Include:

Alex Dranov, M.D.R.A., Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe GmbH & Co. KG

Badr Fathi, PharmD, Global Regulatory Affairs Manager, GlaxoSmithKline Consumer Healthcare

Larisa Reed, Partner, Regulatory Association of CIS Countries

José Manuel Simarro Escribano, IT Director, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

Pieter Vankeerberghen, Head of ICT Products and Developments, Federal Agency for Medicines and Health Products

Elizabeth Davidoff, Regulatory Affairs Senior Manager International, Vifor Pharma Ltd.

Nanita Cranford, Director, Regulatory Operations, Jazz Pharmaceuticals, Inc.

Klaus Menges, Director, Federal Institute of Drugs and Medical Devices (BfArM)

pharmaceutical regulatoryaffairs

GLOBAL

SUMMIT

7 international and EU

regulatory authority speakers

Day One • Tuesday 27 October 2015

Pre-Conference Evening Seminars • Monday 26 October 2015

Stream 1: Regulatory Affairs in Russia, CIS, Turkey and MENA

Stream 2: Regulatory Affairs in Latin America and Asia-Pacific Stream 3: Global eSubmissions

08.30 Conference registration

09.00 Opening remarks from the Chair

Amendments to Russian Law on Circulation of Medicines Regulatory Update: Latin America Telematics Updates and Experience

09.10 Overview of significant Amendments to Russian Federal Law No. 61-FZ “On Circulation of Medicines” (2010) to come into force on 1 July 2015Alex Dranov, M.D.R.A., Senior Regulatory & Scientific Affairs Manager,Dr. Willmar Schwabe, GmbH & Co. KG, Germany

Case study: Best practice for product registration in BrazilDarius-Jean Namdjou, International Regulatory Project Lead, Grünenthal GmbH, Germany

Comprehensive overview of the finalised Telematics Strategy implementation program for Europe: What is upcoming and when?Juha-Pekka Nenonen, Director, Information Resources, Finnish Medicines Agency, Finland

09.45 Clarifying the need to follow Russian CTD format for registration dossiers with the recent Amendments to the Russian Federal Law No. 61-FZElizabeth Davidoff, Regulatory Affairs Senior Manager International, Vifor Pharma Ltd., Switzerland

Case study: Best strategies for successful Marketing Authorisation Application (MAA) submissions in MexicoBirgitta Hedin, Head of Regional Regulatory Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Regulator Exploring the use and practical implementation of the Common Repository

José Manuel Simarro Escribano IT Director, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Spain

10.20 Reviewing how drug interchangeability is to be defined and established following the recent Amendments to the Russian Federal Law No. 61-FZBernhard Kolmerer, Head Regulatory Affairs International, Vifor Pharma Ltd., Switzerland

Understanding and practically meeting regulatory requirements in Argentina for successful market entryIngrid Mueller, Emerging Markets Regulatory Affairs Manager, Boehringer Ingelheim Pharma GmbH & Co, KG, Germany

Reviewing latest updates on the PSUR Repository and implications for industryChantal Le Floch, Regulatory Affairs Division Director – Registrations Europe, Servier, France

10.55 Networking and morning coffee

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TOP TABLE PANEL DISCUSSION: Sharing experiences with key changes and innovations with the Amendments to the Federal Law No. 61-FZ Panellists include: Alexander Khokhlov, Professor, Head of the Dpt. Clinical Pharmacology, Yaroslavl State Medical Academy (and Vice Chair of Central Ethical Committee, Ministry of Health of Russia), RussiaAlex Dranov, M.D.R.A., Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe GmbH & Co. KG, Germany

Clarifying the regulatory environment and ensuring successful registration in ColumbiaDr Meike Vanhooren, Senior Director, Pfizer, Belgium

Understanding the successful integration of electronic application forms (eAF) into European submissionsAlastair Nixon, Director, Global Submission Production, Pharmaceuticals, GlaxoSmithKline Research & Development Ltd, UK

Pre-Conference Evening Seminar (W)Registration is at 18:00 for an 18:15 start. The seminar will finish no later

than 20:30. Seminar documents and an evening networking dinner will be provided.

Designing and Conducting Multi-Regional Clinical Trials in the Emerging Markets

In recent years, drug development has become dramatically globalised, and multi-regional clinical trials (MRCT) are now being extensively conducted in emerging markets. Whilst these trials can accelerate development processes and shorten approval time, they do come with challenges. This interactive seminar session will provide attendees with a comprehensive insight into optimal MRCT design and conduct.Topics to be discussed include:• Understanding how to design MRCT that successfully address

local population needs• Case examples of successful MRCT design and conduct• Clarifying the extent to which MRCT reduce approval time and

documentation requirements for clinical trial applications• Examining the key pros and cons of carrying out MRCT• Outlining the latest requirements and challenges for MRCT

involving study sites in China• Overcoming coming key challenges experienced when carrying

out MRCTLed by: Jacquie Mardell, Principal, Anhvita BioPharma Consulting Inc., USA Larisa Reed, Partner, Regulatory Association of CIS Countries, SwitzerlandPlease see the website for further details – www.GPRAS.com

Pre-Conference Evening Seminar (S)Registration is at 18:00 for an 18:15 start. The seminar will finish no later

than 20:30. Seminar documents and an evening networking dinner will be provided.

Discovering the Latest Developments, Practicalities and Implications of eCTD v4.0/RPS

Recent developments such as the successful ballot at HL7 on RPS Release 2 becoming an ANSI standard, represent a significant step towards the implementation of eCTD 4.0. This new version of eCTD, expected to reach ICH Step 4 in November 2015, utilises a completely different technical approach to the electronic submission of an eCTD message.Teams from across industry are studying available materials in order to prepare for the significant changes ahead. Get a head start on understanding this complex new specification by attending this evening session where you will hear the latest news and updates from ongoing work at ICH, and be provided with a non-technical overview of the new specification.Use this seminar to prepare for the practicalities of working with eCTD v4.0 and transitioning from eCTD v3.2. Expert speakers will divulge information on the following:• What’s the latest in the story of eCTD v4.0?• Highlighting timelines for development and planned implementationPlease note that given the changing nature of eCTD v4.0, not all aspects of the seminar can be presented based on fixed results or confirmed decisions.Led by: Harv Martens, President, ING America & Technical Expert on ICH M8 and M2 Expert Working Groups, USAPlease see the website for further details – www.GPRAS.com

Practical Experiences with Registration in Russia

12.00 Practical advice for successful registration in Russia including any experience with the Amendments to Federal Law No. 61-FZ (2010)Badr Fathi, PharmD, Global Regulatory Affairs Manager, GlaxoSmithKline Consumer Healthcare, Switzerland

Regulatory update and practically meeting requirements in VenezuelaVirginie Rivas, Professor, Switzerland

Best practice for developing and implementing strategies for eCTD only DCP and MRP submissions Suzie Henderson, Principal Global Submission Manager – Submissions and Information Management, Takeda Development Centre Europe, UK

Spotlight presentations – please contact Linda Cole for more information:[email protected] or call +44 (0) 20 7017 6631


Spotlight presentations – please contact Chamatkar Sandhu for more information:[email protected] or call +44 (0) 20 7017 7278

12.35 Networking lunch

13.35 Case study: Sharing experience with Amendments to Federal Law No. 61-FZ (2010) and successful registration in Russia Anna Litsiou, Associate Regulatory Affairs Director, Astellas, The Netherland

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INTERACTIVE EXPERIENCE EXCHANGE: Sharing experiences with registration in Latin American countries

A highly interactive session where attendees will be split into small groups to enable them to share solutions to common problems with other attendees.

Key updates and progress with the Single Submission Portal combined CESP/GatewayClaudia Pyne, Publishing Manager, Allergan Limited, UK

Generics Requirements in Russia Clinical Trials in Latin America

14.10 Generics perspective: New Russian law on amendments 429-FZ as of 22-Dec-2014 Dr Mikhail Tikhonov, CEO, ARS PharmRussia, Russia

Case study: Practically carrying out clinical trials and meeting requirements in BrazilAndrea Palluch, Owner, Inpharmedia, UK

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TOP TABLE PANEL DISCUSSION: EU Telematics

Joined by speakers from the session

14.45 Networking and afternoon tea

Eurasian Union Filing Variations & Pharmacovigilance in Latin America

Regulatory Operations and Publishing: Practical Considerations

15.15 Exploring the current status of the Eurasian Union and expectations for impact on industryBéatrice Huret, Regulatory Area Leader, Eastern Europe, Chief Medical Officer Department, Sanofi Pasteur, France

Optimal strategy to file variations in Latin American countries – past present & futureAyaz Hameed Khan, Director, Regulatory Affairs, Grünenthal GmbH, Germany

Case study: Exploring the structural set up and operational management of a Submissions Management groupJames Hendry, Head of EU Submissions Management, Teva, UK

15.50 Outlining possible risk mitigation plans and industry solutions to meet the requirements of the new regulatory environmentAlexandra Kitashova, MENA & CIS Area Regulatory Hub Head, GlaxoSmithKline Pharmaceuticals, Russia

Understanding and practically implementing pharmacovigilance and risk management requirements in Latin AmericaLisa Ruiz, Latin America Area Head, AbbVie Inc., USA

Small/medium company perspective: Outlining the structural set up and operational management of regulatory operations Nanita Cranford, Director, Regulatory Operations, Jazz Pharmaceuticals, Inc., USA

16.25

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Extended Q&A discussion: Impact of the Eurasian Union on industryJoined by speakers from the session

Case study: Successfully outsourcing regulatory publishing and overcoming key challengesRichard Knowles, Publishing Manager, Global Dossier Management, Ipsen Biopharm Limited, UK

17.00 Networking drinks reception

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Sharing best practice and strategies for successful emerging market submissionsCarolline Petersen, Project Manager, Novo Nordisk A/S, Denmark

17.35 Networking drinks reception

18.00 Evening Experience Exchange: Best Practice for Filing Variations in Russia and CISGrab a drink and join this dedicated seminar session, providing a comprehensive insight into best practice for filing variations in Russia and CIS countries, including latest regulatory requirements and overcoming key associated challenges.Topics to be discussed include:• Determining whether the Amendments to Federal Law No. 61-FZ “On Circulation of

Medicines” (2010) will impact filing variations• Practical advice on filing variations including: - Which documents need to be submitted for each type of variation? - What variation approval timelines can be expected?Led by:Alex Dranov, M.D.R.A., Senior Regulatory & Scientific Affairs Manager, Dr. Willmar Schwabe GmbH & Co. KG, GermanyVictoria Andalibi, General Director, OOO Global Pharma, RussiaPlease visit www.GPRAS.com for full details of this session.

Evening Experience Exchange: Regulatory Operations and PublishingAn extended session designed to enable team members to share strategies and experiences on a range of challenges encountered in the management of regulatory operations teams and functions. Take a drink and move between discussion tables as participants trade company strategies and personal perspectives.Attendees are encouraged to bring company cases and current challenges to discuss with industry peers and experts.Led by speakers from the sessionPlease visit www.GPRAS.com for full details of this session.

19.30 Close of Evening Experience Exchange

19.35 End of conference day one

“Great networking opportunity and sharing of knowledge” (Associate Director, Takeda – 2014 Attendee)

Day Two • Wednesday 28 October 2015


Stream 2: Regulatory Affairs in Latin America and Asia-Pacific Stream 3: Global eSubmissions


Regulatory Updates: CIS Countries Asia-Pacific Regulatory Update Feedback from European Regulatory Authorities

09.10 Assessing the regulatory environment and practical advice for market entry in UkraineLarisa Reed, Partner, Regulatory Association of CIS Countries, Switzerland

Case study: Navigating regulatory requirements in China for successful product registration Prasanna Kumar Thenneti, Head, Regulatory Affairs – Emerging Markets, Dr. Reddy’s Laboratories, India

Regulator BfArM feedback, plans and advice for successful eSubmissions

Klaus Menges, Director, Federal Institute of Drugs and Medical Devices (BfArM), Germany

09.45 Essential regulatory update and best practice for registration in KazakhstanLuka Lukšic, Regulatory Affairs Manager, Jadran – Galenski laboratorij (JGL) d.d., Croatia

Clarifying the current regulatory framework and authority structure in IndiaDolorès Edmont, Independent RA Consultant, E.U.R.L. L2D Consulting 34, France

Regulator FAMHP feedback, plans and advice for successful eSubmissions

Pieter Vankeerberghen, Head of ICT Products and Developments, Federal Agency for Medicines and Health Products, Belgium

10.20 Evaluating the regulatory environment and practical advice for registration in Moldova, Azerbaijan and Uzbekistan Pelin Boran, Owner, Pelin Boran Regulatory Affairs Solutions and Consultancy, Turkey

Case study: Best strategies for successful product registration in India Nagesh Maddula, Independent RA Consultant, Biovision Consultants Limited, UK

Presentation to be delivered by INFOTEHNA

Please see the website for further details - www.GPRAS.com


11.25

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ORLD CAFE

Global eSubmissions

CIS COUNTRIES INTERACTIVE WORLD CAFÉ: Sharing experiences with submitting Marketing Authorisation Application (MAA) in the CIS countriesDiscussion areas include:Ukraine Dr Anna Pogodaeva, Executive Director, Pharmagate Ltd, Ukraine Other CIS countries Pelin Boran, Owner, Pelin Boran Regulatory Affairs Solutions and Consultancy, Turkey

Understanding the regulatory environment and practical considerations for market entry in South KoreaDr Stefan Bartel, Group Head INT Asia Pacific, Bayer Pharma AG, Germany

Exploring latest updates and sharing practical experiences with eSubmissions in Saudi Arabia, Oman and the GCC regionCecilia Limberg, Associate Director Submission Management, AstraZeneca, Sweden

Russian Normative Document

12.00 Corporate maintenance of the Russian Normative DocumentAlessandra Leone, Global CMC Manager, Pfizer Consumer Healthcare, Italy

Exploring Taiwan’s regulatory framework and practical advice for product registrationDr Gabriele Wirtz, Global Regulatory Affairs Manager, Bayer Pharma AG, Germany

Reviewing latest updates and sharing practical experiences with eSubmissions in AustraliaMelanie Ruppel, Global Submission Manager, Global Regulatory Affairs, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany



Spotlight presentations – please contact Chamatkar Sandhu for more information:[email protected] or call +44 (0) 20 7017 7278


Clinical Trials in Russia and CISGlobal Dossier Concept: Managing

Global Submissions

13.35 Case study: Best strategy for conducting clinical trials in RussiaVictoria Andalibi, General Director, OOO Global Pharma, Russia

Reviewing latest regulatory progress in the ASEAN countries and impact on industryDavid Jefferys, Senior Vice President, Eisai Europe Ltd, UK

Global Dossier Concept: Managing global submissions in a synchronised and harmonised wayAndrea List-Gosten, Global Submission Leader, Bayer Pharma AG, Germany

14.10 Working With Affiliates and External Partners

Regulator Clinical trials in Ukraine: Current regulatory environment and latest changes in the Ministry of Health

Natalia Bogdan, Ministry of Health, Ukraine

Overcoming key challenges with product registration in the ASEAN region Magda Kozlowska-Krupa, Regulatory Affairs Specialist, Adamed, Poland

Successfully managing submissions with affiliates and external partnersKatrin Spaepen, Director Strategy Vault Submissions, Veeva Systems, Belgium


“Great opportunity to catch up on all the latest developments whilst making new connections”(Head of EU Submissions Management, TEVA – 2014 Attendee)

Asia-Pacific World Café Session US eCTD Submissions

15.15 Benefits from carrying out clinical trials in CIS countriesVlad Linievych, GCP Auditor and Clinical Research Consultant, Ukraine

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ORL D CAFE ASIA-PACIFIC INTERACTIVE WORLD CAFÉ: Sharing experiences with successful product registration

Save your questions from the session and join a round table dedicated to your region of choice. Join the speaker and other attendees as they share experiences on the challenges faced in a highly interactive environment. Get your questions answered before joining another table concerning another case study.Led by speakers from the session

Reviewing latest developments and practical implications for changes to US Module 1 (version 2.3)

Lois Householder, Director Regulatory Operations, Lundbeck, USA

Localisation of Drug Manufacturing in Russia eSubmission Archiving

15.50 Understanding the push towards localisation of drug manufacturing in Russia and impact on industryFrançois-Xavier Routhier, Head Eurasia & South Asia / Global Regulatory Affairs, Sanofi, France

Reviewing real life archiving systems and processes and key considerations for eSubmission archiving projectsJaana Pohjonen, Specialist of Record Management and Archives, Quality Manager, Fimea, Finland

16.25 End of conference day two

Day Three • Thursday 29 October 2015


Stream 2: Regulatory Affairs in Latin America and Asia-Pacific

Stream 3: Global eSubmissions


Registration and GMP Site Audits in Turkey

Focus Sessions: Australia and Japan IDMP Implementation

09.10 Understanding the regulatory requirements and practical advice for product registration in TurkeyMerve Esendagli, Senior Regulatory Affairs Associate, Reckitt Benckiser, Turkey

Reviewing the regulatory framework and strategies for successful product registration in AustraliaSimone Granchi, Corporate International Regulatory Affairs, Menarini Richerche S.p.A., Italy

Coming into compliance with IDMP: Examining what the ISO standards entail and how business processes will be impactedDieter Schlaps, Owner, IT-Consulting Life Science, Germany

09.45 Generics perspective: Practical advice for product registration in TurkeyAyla Deliorman, Head of Regulatory Affairs, Santa Farma Pharmaceuticals, Turkey

Case example of successful submission for new product registration in JapanSyham Ayache, Regulatory Compliance Project Leader, Galderma, France

Presentation to be delivered by Parexel



Clinical Trials and Filing Variations in Asia-Pacific

10.50 Establishing best strategies to overcome challenges with GMP site audits in TurkeyDeniz Cigdem AKYÜREK, Regulatory Affairs Manager, Abdi Ibrahim Pharmaceuticals, Turkey

Practically carrying out and meeting requirements for clinical trials in Asia-PacificOlga Apryshkina, Clinical Trial Head, Novartis, Switzerland

Meeting the July 2016 IDMP implementation deadline: What should you be doing to prepare? Ida Bastian Jensen, ISO IDMP Manager, Bayer, Switzerland

MENA: Regulatory Updates and Registration

11.25 Navigating the regulatory environment and best strategies for product registration in Saudi ArabiaHanaa El-Azzami, Regulatory Associate / Business Development MENA, PHARMALEX Middle Near East FZ-LLC, Dubai

Determining best strategies for filing a variation and gaining approval in Asia-PacificDr Valérie Vanweyenberg, Director, GRA-CMC Team Leader CoE Small Molecules, UCB Pharma S.A., Belgium

Update on XEVMPD/IDMP and the consequences for a RIM strategyChristine Hirt, Managing Consultant, EXTEDO, Germany


Orphan Drugs and Biosimilars Requirements in Latin America

and Asia-Pacific

13.00 Outlining the regulatory framework in the Gulf Coast Council (GCC) including current status of the centralised registration procedureAbdul Mateen, Regulatory Affairs Manager, AstraZeneca, UK

Global marketing application strategy, including orphan drugsMichael G Muña, Regulatory Affairs International, BioMarin Pharmaceutical Inc., USA

IDMP: Meeting the challenges ahead - a case studyPhoebe Naveed, eSubmission Manager, Global Regulatory Affairs, Linde AG, Germany

IDMP & RIM Focus

Day (Y)

Turkey & MENA

Focus Day (X)

“Excellent networking opportunities with likeminded colleagues from industry, regulatory authorities and vendors”

(Performance Manager, Information Processing Unit, MHRA – 2014 Speaker)

Media Partners

13.35 Assessing the regulatory framework in North Africa and practical advice for market entryPietro Maietta, International Regulatory Advisor, Recordati, Italy

Complying with regulatory requirements for biosimilars registration in Asia-Pacific: Focus on ChinaDr Dr Michel Mikhail, Expert in International Regulatory Affairs and Biosimilars, Germany

Presentation to be delivered by NNIT



14.40

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ORLD CAFE

TURKEY AND MENA INTERACTIVE WORLD CAFÉ: Sharing experiences with successful registrationSave your questions from the session and join a round table dedicated to your region of choice. Join the speaker and other attendees as they share experiences on the challenges faced in a highly interactive environment. Get your questions answered before joining another table concerning another case study.

Complying with regulatory requirements for biosimilars registration in Latin AmericaDr Thomas Kirchlechner, Head Regulatory Emerging Markets Group, Global Regulatory Affairs Biopharmaceuticals, Sandoz GmbH, Austria

Case study on managing IDMP data: Key considerations and methods used during data collection phaseInnis Viviers, Associate Director, Regulatory Information Management, Data Standards and Quality, Janssen, Pharmaceutical Companies of Johnson & Johnson, UK

Generics Registration in MENA Regulatory Information Management Insight

15.15 Case study: Practical advice for successful generics registration in MENA Syndie Messager, Market Access and International Regulatory Affairs Coordinator, Laboratorios Cinfa, Spain

Case study: Exploring a biosimilars joint venture between a company operating in regulated markets and a company active in emerging marketsDr Helmut Brunar, Founding Partner, PassionBio – Market Access Partners, Austria

Planning, design and implementation of a RIM system – an SME perspectiveGraham Moody, Associate Director of Regulatory Operations, ARIAD Pharmaceuticals, Switzerland

eCTD Updates: MENA Cloud Solutions and RIM

15.50 Latest updates on eCTD requirements and practical implementation in MENATine Vermeulen, Consultant & Project Manager Pharma Industry, PLANPHARMA, Belgium

Case study: Implementation and maintenance of a cloud-based eDMS and integrated publishing systemRichard Knowles, Publishing Manager, Global Dossier Management, Ipsen Biopharm Limited, UK Nathalie Sarron, Systems Manager, Global Dossier Management, Ipsen, France

Labelling and Packaging Requirements in MENA

16.25 Reviewing the country-specific labelling requirements and degree of dependency on foreign labels in MENAAaron Barzey, Senior Executive - Global Regulatory Affairs, Reckitt Benckiser Pharmaceuticals, UK

Networking drinks reception

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17.00 Grab a drink and make your way to one of the extended evening sessions

17.15 Evening Experience Exchange: Practical Advice for Successful Product Registration in South AfricaThis focused seminar session will provide a detailed update on the current South African regulatory environment as well as practical advice and the chance to interactively share experiences and challenges for successful registration in the region.

Topics to be discussed include:

• Outlining the current regulatory environment in South Africa and any upcoming or recent changes

• Successfully registering in South Africa including managing the long timelines involved with the approval process

Led by:Dr Andrea Sisneros, Director, Riodove Services Limited, UK

Please visit www.GPRAS.com for full details of this session

IDMP Evening Experience Exchange: How Have Other Companies Implemented IDMP Projects? This extended evening session provides the opportunity to interactively share experiences and challenges related to the implementation of IDMP projects.

Attendees are encouraged to bring company cases and current challenges to discuss with industry peers and experts.

Topics to be discussed include:

• What approaches are being taken for successful implementation?

• What stage of implementation are different companies in?

Led by:Dieter Schlaps, Owner, IT-Consulting Life Science, Germany

Please visit www.GPRAS.com for full details of this session

18.30 Close of Evening Experience Exchange

18.35 End of conference

The Conference Networking

11 Interactive Sessions

1 eSubmissions day dedicated to IDMP

200+ attendees

IDMP

42% Regulatory Affairs

12% Submissions

10% Regulatory Operations

7% Publishing

21% Heads/Directors

8% Other

2%

What companies do attendees come from?

Where did the delegates come from in 2014?

Source new prospects, leads and ultimately sales at the Global Pharmaceutical Regulatory Affairs Summit 2015

• Speak on the agenda• Exhibit at the event• Host the evening drinks reception• Sponsor a webinar• Sponsor the delegate bag & lanyards• Attend as a promotional participant instead of a

delegate

For sponsorship and exhibition opportunities please contact Linda Cole. Email. [email protected] Tel: +44 (0) 20 7017 6631

Sponsors & Exhibitors

“This conference was beneficial for INFOTEHNA! The event covers interesting topics and also gives a great opportunity to network. In the future, we will definitely attend with a larger group of people”

INFOTEHNA

“The event was a great opportunity to connect with our clients and prospective clients to speed up the sales process and access new people”

PAREXEL

3 days

3 streams

pharmaceutical regulatoryaffairs

GLOBALSUMMIT

Large Pharma34%

Small/Medium Pharma

Generics

Biopharmaceuticals

Regulatory Agencies

Independent Consultants Other

33%

12%

9%5%

5%

Networking opportunities rated:

Northern Europe 8%

Eastern Europe 16%

Australia 1%

Central Europe 39%

Southern Europe 15%

UK 19%

USA 2%

NEW for 2015: Beyond conference attendance - taking your message globalWebinar Sponsor

3 Easy ways to register www.GPRAS.com

Conference Documentation: Cannot Attend? For those busy executives who cannot take full advantage of this event, the papers give you a useful record of the presentations made at the event. The set of speakers papers and/or slides from the conference is available after the event for £699 +20% VAT. Contact Customer Services on tel: +44 (0) 20 7017 7481, fax: +44 (0) 20 7017 7823 or email: [email protected].

Terms and ConditionsFEE: This includes all technical sessions, refreshments, lunch and access to speakers’ presentations that we have permission to make availableCANCELLATIONS: Cancellations received in writing before and on Monday 12th October 2015 will be subject to a service charge of £99. The full conference fees remain payable after Monday 12th October 2015. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organiser to alter the content and timing of the programme or the identity of the speakers. In the unfortunate event that an event is cancelled Informa are not liable for any costs incurred by delegates in connection with their attendance. This contract is subject to English Law.ARE YOU REGISTERED?: You will always receive an acknowledgement of your booking. If you do not receive anything, please call us on +44(0) 20 7017 7481 to make sure we have received your booking.Due to unforeseen circumstances, the programme may change and Informa reserves the right to alter the venue and/or speakers. ©Copyright Informa BV, 2015. Yes I agree to the terms and conditions as stated on this form.

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Venue Details: Hotel Palace Berlin, Budapest Str. 45, 10787, Berlin Tel.: +49 30 2502 0Fax: +49 30 2502 – 1119 [email protected] www.palace.deACCOMMODATIONReduced rate accommodation: the cost of accommodation is not included in the conference fee. To book reduced rate accommodation please visit the section “Accommodation” on the conference website www.GPRAS.com. Please book early to avoid disappointment.

Global Pharmaceutical Regulatory Affairs Summit27-29 October 2015 | Hotel Palace Berlin | Berlin | Germanywww.GPRAS.com

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Pass Book before 7th August 2015 SaveBook between 7th August and

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1 Day Pass*: Focus Day £1149 + VAT £200 £1249 + VAT £1349 + VAT

2 Day Pass** £1699 + VAT £200 £1799 + VAT £100 £1899 + VAT -

Full pass: 3 days £2748 + VAT £300 £2848 + VAT £200 £2948 + VAT £100

*1 Day pass only available for ‘IDMP & RIM’ or ‘Regulatory Affairs in Turkey and MENA’ Focus Day (Conference Day 3)**2 Day pass only available for conference days 1 & 2

Please select your focus day (Thursday 29th October): Regulatory Affairs in Turkey and MENA Focus Day (X)

IDMP & RIM Focus Day (Y)

Upgrade your pass :Individual Evening Seminar** (can only be booked as part of a 2 or 3 day pass) £499 + VAT

This applies to the pre-conference evening seminars (please select one of the following)

Please select your evening seminar (Monday 26th October): Pre-Conference Evening Seminar (W): Designing and Conducting Multi-Regional Clinical Trials in the Emerging Markets

Pre-Conference Evening Seminar (S): Discovering the Latest Developments, Practicalities and Implications of eCTD v4.0/RPS

Please select your pass:

For group bookings, please contact Michael Dunnet, Tel: +44 (0) 20 7017 7870 Email: [email protected]

LS/A

P/LC

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Rpharmaceutical regulatoryaffairs

GLOBAL

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To register, please contact your Key AccountManager, Hannah Caldwell, on:

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