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 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 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 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 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 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
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