Susanne Brendler-Schwaab

ESTP Congress
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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 different units at the BfArM responsible for regulatory affairs and project management for all kinds of regulatory procedures and therapeutic areas.

Mrs. Brendler-Schwaab was the chair of the former safety working party (SWP) since October 2021 and is the current chair of the Non-clinical Working Party (NcWP) at the European Medicines Agency (EMA) since April 2022. In addition, she was involved in the work of the SWP ICH S1 subgroup performing an independent review of CADs as a prospective evaluation project.