Ever wondered what medicine regulators actually do? In this seminar, representatives from the EMA and a national competent authority will talk about their work. You will hear how researchers and regulators can collaborate on scientific aspects, and how different health professionals can get involved in regulatory activities. It will be a good chance to ask questions, learn something new, and maybe discover a future role you didn’t expect.

Working language: English.

Lecturers

Caroline Pothet is a pharmacist with a master’s degree in Drug Development and Global Registration of Medicines from Paris University. Before joining the European Medicines Agency (EMA) in 2020, she spent 20 years in the pharmaceutical industry in regulatory policy, regulatory affairs and clinical development, covering all stages of development and major submission types (incl. clinical trial applications, paediatric plans, request for scientific advice, orphan designation and marketing applications). From 2010 to 2020, she led regulatory strategy and clinical programme design in oncology and immuno inflammation. Working closely with multidisciplinary teams, she deepened her expertise in clinical and methodological aspects of drug development in these therapeutic areas. At EMA, Caroline initially supported the Committee for Advanced Therapies, Scientific Advice, and the Oncology and Haematology Office. She now heads the Office for Advanced Therapies and Haemato Oncology. She also leads the REVAMP project on optimising assessment reports, supports the Oncology and Haematology Working Parties, and contributes to the clinical study data project.

Frank Pétavy is a mathematician and biostatistician by training. He has worked 14 years in all phases of clinical development in the Pharmaceutical Industry (large and smaller companies, and CRO) before moving to EMA in 2012 where he was Head of Methodology until summer 2024. Frank was recently seconded part-time for one year to the Dutch medicines Agency CBG-MEB where he acted as a statistical assessor in Scientific Advice and Marketing Authorisation Applications. He has a wide experience in the development and review of regulatory guidelines in the methodological, clinical and quality areas at both European and international levels. Frank was deputy topic lead of the ICH E9(R1) on estimands and sensitivity analysis and is now deputy topic lead for ICH E20 on adaptive designs, on behalf of European regulators. At EMA Frank also supports the Methodology Working Party, the methodology domain and the EU community of statistical assessors. 

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