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A Development Support Environment in Europe that Adapts to the Future Challenges of Innovation – Needs and Expectations
Session Chair(s)
Michael Berntgen, PhD
Head of Scientific Evidence Generation
European Medicines Agency, Netherlands
The quest for precision medicines is pushing the boundaries of science, regulatory decision making and knowledge management. Are R&D support mechanisms sufficiently interconnected and adaptable? The session will discuss needs and expectations from various key players.
Speaker(s)
Stages in development when opportunities for dialogue are needed: what do we already have in Europe, and what do we need?
Emma Du Four, MBA
-, United Kingdom
Regulatory and R&D Policy Professional
Reaching out early to developers of innovation and the support through the EU Innovation Network
Christophe Lahorte
Federal Agency for Medicines and Health Products, Belgium
Head of National Innovation Office and Scientific-Technical Advice Unit
Clinical trial authorisation for complex trials and how the CTFG can support their implementation
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Parallel consultation: Which questions to be addressed and when?
Chantal Belorgey-Bismut, DrMed, MD, MHS
Haute Autorité de Santé (HAS), France
Advisor to the HAS President, Vice-chair of EUnetHTA Executive Board
Optimising the adaptability and flexibility of EMA support mechanisms: proposals for reflection
Michael Berntgen, PhD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
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