Brigitte Brake
BfArM- Federal Institute for Drugs and Medical Devices
Brigitte Brake has been working in the biotech and regulatory field for more than 25 years. In her current position she is head of the Unit “Pharmaceutical Biotechnology, Inspections” at the Federal Institute for Drugs and Medical Devices (BfArM), Germany. At the European level she represents BfArM in the CHMP Biologics Working Party (BWP). She is also a lecturer in the postgraduate course “Master of Drug Regulator Affairs” at Bonn University. She contributed to the drafting and implementation of many concept papers and guidelines on the quality and pharmaceutical/biological development of biotech products and was actively involved in the ICH process.