Unit head at the German Federal Institute for Drugs and Medical Devices (BfArM), Senior Expert in Toxicology and Regulatory Affairs
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 of human medicinal products. She used to be the chair of the former safety working party (SWP) and the vice chair of the former J3Rs Working Group at the European Medicines Agency (EMA). After restructuration of the non-clinical domain at EMA she is now the chair of the new non-clinical Working Party (NcWP) since April 2022.