Frauke Naumann-Winter | Head of Unit
BfArM

Frauke is a biologist and regulatory scientist with a background in molecular genetics, epidemiology, evidence-based medicine and oncology. She obtained her PhD in Molecular Biology (Genetics) from the University of Cologne and holds a European MSc in Epidemiology from the University of Mainz. Before joining the German Federal Institute for Drugs and Medical Devices (BfArM) in 2007 as a clinical assessor in oncology, she worked at the editorial base of the Cochrane Haematological Malignancies Group at the University of Cologne. Since 2013, she has served as the German representative on the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) and has been Vice-Chair of the COMP since 2024. Her regulatory and scientific work focuses particularly on orphan medicinal products, rare diseases, oncology, regulatory evidence requirements, and the use of real-world and external data across the broad spectrum of regulatory decision-making.