Senior Drug Regulatory Affairs Expert and Managing Director of Phact GmbH
Modules
Translational Medicine and Biomedical Entrepreneurship
Module 4 - Regulatory Affairs
Biography
Barbara is a Senior Drug Regulatory Affairs Expert with more than 28 years of experience in the area of Drug Regulatory Affairs. Her professional focus is on supporting companies in developing optimal registration strategies for their newly developed medicinal drug products. Special attention is given to support the implementation of science-and risk-based principles according to ICH Q8 to Q11.
Barbara is an experienced trainer who has conducted numerous public and in-house training courses worldwide. She also lectures at various Swiss universities (ETHZ - Swiss Federal Institute of Technology Zurich; FHNW - University of Applied Sciences and Arts Northwestern Switzerland; Bern University of Applied Sciences) and at the School for Translation and Entrepreneurship in Medicine, sitem-insel AG, Bern.
As an editor and co-author she published the second edition of a book titled ‘Pharmaceutical Legislation of the European Union, Japan and the United States of America – An Overview’ (Second Edition 2016) issued by the Parenteral Drug Association, Inc., Bethesda, MD 20815, US.
Barbara graduated in pharmacy from the Johann-Wolfgang-Goethe University of Frankfurt/Main, Germany, and obtained a doctorate in pharmaceutical chemistry from the Eberhard-Karls University of Tübingen/Germany in 1990. In 1991 she was certified as an external regulatory affairs expert at the German Federal Institute for Drugs and Medical Devices (BfArM) and worked in this function as an expert/assessor until 2006. In 2006, she co-founded the Swiss-based independent consultancy Phact GmbH.
