14th EGA Regulatory and Scientific Affairs

14th EGA Regulatory and Scientific Affairs Conference
Meeting Future Challenges and Opportunities
of the Regulatory Environment
22 – 23 January 2015
Radisson Blu Portman Hotel
22 Portman Square, London W1H 7BG, UK
Thursday 22 January 2015
14th EGA Regulatory and Scientific Affairs Conference
08:00 Registration and networking coffee
09:00 Opening Session – New EU political landscape - how will it impact pharmaceutical policy?
Chair  Adrian van den Hoven, Director General, European Generic medicines Association
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Priorities of the new European Commission related to pharmaceuticals  Andrzej
Rys, Health Systems and Products Director, DG SANCO, European Commission
Improving the efficiency of the current regulatory system - outcome of the EGA project
 Beata Stepniewska, Deputy Director General and Head of Regulatory Affairs, EGA
Perspective of Competent Authorities
o Guido Rasi, on behalf of the European Medicines Agency (EMA)
o Xavier De Cuyper, FAMHP (BE) on behalf of the Heads of Medicines Agencies
(HMA) Management Board
Panel Discussion composed of session speakers and Caroline Kleinjan, Chair EGA
Regulatory and Scientific Committee, Sandoz
10:45 Networking coffee break
11:15 Session 2 – Opportunities and challenges of globalisation
Chair  Martin Harvey Allchurch, Principal International Affairs Officer, EMA and Gary
Clapp, Vice President, EMEA Regulatory Affairs, Mylan
 Does the regulatory framework facilitate global access and international regulatory
strategy for generic medicines?  Gary Clapp, Mylan
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o Industry’s product development and international filing strategy
o More convergence possible?
Various international initiatives - State of play, interaction, industry as a partner
Peter Bachmann, BfArM (DE) and Lenita Lindstrom-Gommers, EC, DG SANCO
Experience with the pilot project (IGDRP)  Adrian Andrews, Teva
Q&A Session with a panel composed of session speakers and kind participation of Andrzej
Rys, Health Systems and Products Director, DG SANCO, European Commission
13:00 Networking buffet lunch
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209
14:00 Session 3 – Future European Telematics environment - which direction do we take and
how can we be prepared?
Chair  Remco Munnik, Chair of the EGA Telematics WG, Combinopharm and Alexis Nolte,
Head of Procedure Management & Business Support Division and Head of Information
Technology Division ad interim, EMA
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Future EU telematics environment - watch this space!  Constant van Belkum, MEB
(NL) and Remco Munnik, Combinopharm
 EU Telematics Strategy
 New role of the Change Control Board – how to handle the change control
process?
 Change from XEVMPD to ISO IDMP - how would it impact authorities and
companies?
 How to break the silos between various initiatives and to achieve better
standardisation and interlinking between projects?
Q&A Session with a panel composed of session speakers
15:15 Networking coffee break
15:45 Session 4 – Ideal Decentralised Procedure: can a dream come true?
Chairs  Caroline Kleinjan, Chair EGA Regulatory and Scientific Committee, Sandoz and
Christer Backman, Vice Chair, CMdH, MPA (SE)
 10 years’ experience with the DCP
o Does DCP need refreshing? CMDh and Industry observations  Marta
Marcelino, INFARMED (PT) and Stella Koukaki, Pharos
 “Dream DCP” - the EGA proposal for improvements  Caroline Kleinjan, Sandoz
Q&A Session with a panel composed of session speakers and Virginie Bacquet, ANSM (FR)
17:00 Closure of the day
19:30 Conference dinner  Informal Attire
Friday 23 January 2015
14th EGA Regulatory and Scientific Affairs Conference
08:00 Welcome coffee
TWO parallel technical tracks (please advise choice when registering)
TRACK ONE – REGULATORY IMPLICATIONS OF DEVELOPMENTS IN THE LEGAL AND
OPERATIONAL ENVIRONMENT- IMPACT ON SUPPLY CHAIN
09:00 Session 5A – Supply Chain resilience and agility: What is the state of play in the EU?
Chairs  Brendan Cuddy, Head of Manufacturing and Quality Compliance Service, EMA and
Jan Moors, Chair of the EGA Quality and Compliance WG and VP Commercial Quality, Teva
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209
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Managing API Supply Chains Key Sore Points from the generic medicines industry
perspective  Mechthild Sander, Alfred E. Tiefenbacher
 Medicines shortages:
o Perspective of a National Medicines Agency  Ian Rees, MHRA (UK)
o Overview of industry and professional associations’ collaborative approach to
EMA initiative on medicines shortages  Elke Grooten, Sandoz
Q&A Session with a panel composed of session speakers
11:00 Networking coffee break
11:30 Session 6A – Pharmaceuticals in the environment
Chairs  Henry Stemplewski, Expert Toxicologist, MHRA, UK and Elizabeth Girardi-Schoen,
Teva
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Pharmaceuticals in the environment (PIE)  Tom Hargreaves, Blue Frog Scientific
Limited
 The Eco-Pharmaco-Stewardship (EPS) initiative: a joint industry approach on PIE 
David Eherts, Actavis
Q&A Session with a panel composed of session speakers
13:00 Networking buffet lunch
TRACK TWO – LATEST DEVELOPMENTS IN THE ELECTRONIC SUBMISSION ENVIRONMENT
09:00 Session 5B – Technical aspects of submission of information on medicinal products in the
EVPRM format
Chairs  Constant van Belkum, Deputy Director, MEB (NL) and Javier Monvoisin, Teva
Next steps in submission of information on medicinal products in the EVPRM format in
accordance with Art 57 of the new pharmacovigilance legislation  Ilaria del Seppia, EMA
and Vito Strasberger & Katja Pecjak, Billev Pharma on behalf of the industry
 Overview of the submission process and dealing with pending issues
 Maintenance of data
 What is planned for 2015?
 Calculation of Pharmacovigilance fees based on information provided to the Art 57
database
10:00 Roadmap towards ISO IDMP - The implementation of international standards for
identification of medicinal products
 From XEVMPD to ISO IDMP: overview of the differences in the data model  Christian
Kravogel, SeicoDyne GmbH
 Road map towards ISO IDMP  Kepa Amutxastegi, EMA and Javier Monvoisin, Teva
on behalf of the industry
Q&A Session with a panel composed of session speakers
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209
11:00 Networking coffee break
11:30 Session 6B – Initiatives to improve the regulatory environment by effective use of
electronic tools
Chairs Karin Grondahl, Head of the unit for Registration and Information Management,
MPA (SE) and Remco Munnik, Combinopharm
 Common European Submission Platform (CESP) and gateway as effective tools to
improve electronic submission in the EU - dialogue between the authorities and
industry Karin Grondahl, Head of the unit for Registration and Information
Management, MPA (SE), Olivier Simoen, EMA and speaker for industry (TBI)
 Case study of implementation of the current eAF-  Georg Neuwirther, Head of IT
Austrian Medicines and Medical Devices Agency, AGES (AT) and Johanna Walter,
ratiopharm/ TEVA on behalf of the industry
Q&A Session with a panel composed of session speakers
13:00 Networking buffet lunch
Common session
14:30 Session 7 – Put your questions to the Regulators
Chairs  Christer Backman, MPA (SE) and Caroline Kleinjan, Sandoz
An opportunity to address questions to the European Regulators on various regulatory issues.
Questions should be formulated generally, without reference to a given product/procedure
and should be sent 2 weeks in advance to [email protected]
Q&A Session with representatives from the EU authorities: Susanne Winterscheid, BfArM
(DE)  Joan Boye, DHMA (DK)  Zaide Frias, EMA  Marta Marcelino, INFARMED (PT) 
Kora Doorduyn-van der Stoep, MEB (NL)  Keith McDonald, MHRA (UK)
16:00 End of conference and networking coffee
SEE YOU NEXT YEAR ON 28-29 JANUARY 2016!
For further information and to register on-line, please visit:
www.egagenerics.com or http://www.egaevents.org/rac.htm
Lucia Romagnoli - T: +44-7562-876873 - E: [email protected]
Registrations close officially on 15 January 2015 and are subject to availability.
EUROPEAN GENERIC MEDICINES ASSOCIATION AISBL (EGA)
Rue d’Arlon 50, B-1000 Brussels, Belgium
T: +32-(0)2-736 8411 F: +32-(0)2-736 7438
E: [email protected] www.egagenerics.com
VAT: BE 0449 332 209