Unit head for preclinical assessment of clinical trials at the German Federal Institute for Drugs and Medical Devices (BfArM)
Mrs. Brendler-Schwaab graduated in Biology (diploma) at the University of Bonn. Her principal areas of expertise are toxicology and regulatory affairs.
After her PhD at the German Cancer Research Centre in Heidelberg she worked at the German Health Agency in Berlin. Subsequently, she joined Bayer Healthcare in Wuppertal in June 1990. For about 15 years she was study director for genotoxicity-, short term carcinogenicity-, acute-, subacute- and subchronic toxicity studies. In 2004, she became unit head for preclinical assessment of clinical trials at the German Federal Institute for Drugs and Medical Devices (BfArM) in Bonn. Since then she headed further units at the BfArM responsible for regulatory affairs and project management for all kinds of marketing authorisations. She is the German member and since October 2019 the vice chair of the safety working party (SWP) at the European Medicines Agency (EMA). In addition, she is the vice chair of the EMA J3Rs Working Group.