Head of Advanced Therapies - Human Medicines Division
European Medicines Agency, Netherlands
Caroline Pothet is working at the European Medicines Agency since September 2020 and is the acting head of advanced therapies at the European Medicines Agency since October 2022; In this new role. Caroline is also a member of the Regulatory Scientific Committee (RSC) in the International Rare Disease Research Consortium (IRDIRC). Prior to this, Caroline was working as a Senior Regulatory Specialist, providing regulatory, scientific and procedural advice to EMA staff, Scientific Committees (including the Committee on Advanced Therapies) and external stakeholders during the development, evaluation and surveillance of oncologyand haematology medicinal products and Advanced Therapies. Before joining the Agency, Caroline worked in the Pharmaceutical Industry holding various positions in Global R&D & Regulatory Affairs between 1998 and 2020, including more than 15 years in Oncology and immuno-inflammation drug development and registration. Caroline has a Doctorate in Pharmacy and Master in Drug Development and International Regulatory Affairs.
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Making full use of early access and regultatory tools available to ATMPs
Thursday, May 11, 2023
11:45 – 12:45 CEST