This session will discuss the recent initiatives and plans that will affect the regulatory environment for advanced therapy medicinal products (ATMPs) in Europe, such as the EC Pharmaceutical Strategy, the forthcoming implementation of the new Clinical Trial Regulation, GMO requirements for gene therapies, and the European Regulatory Network Strategy to 2025. The impact of these developments on patient access to ATMPs, on the ATMP sector in Europe, and on regulatory bodies will be addressed.
Chair:
Miguel Forte, CEO, Bone Therapeutics
Speakers:
Karolina Hanslik, Senior Project Manager, EURORDIS
Ana Hidalgo-Simon, M.D., Ph.D., Head of Advanced Therapies, European Medicines Agency (EMA)
Rocio Salvador Roldan, Policy Officer, Unit B4- Medical Products, Directorate-General for Health and Food Safety (DG SANTE), European Commission
Martina Schüssler-Lenz, M.D., Chair, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA); Senior Clinical Assessor for ATMPs, Paul-Ehrlich-Institut
