University lecturer, Module 'Regulatory Affairs'

Barbara is a Senior Drug Regulatory Affairs Expert with 26 years of experience in the area of Drug Regulatory Affairs in the field of small molecule and biotech medicinal drug products. In addition to her activities at PhACT, she lectures at ETHZ (Swiss Federal Institute of Technology Zurich), FHNW (University of Applied Sciences and Arts North-western Switzerland) Muttenz/Basel and at the SITEM-Insel school in Berne (Swiss Institute for Translational and Entrepreneurial Medicine). 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: Bundesinstitut für Arzneimittel und Medizinprodukte) and worked in this function as an expert/assessor until 2006. During that time (1991 to 1999) she was also owner of a public pharmacy in Germany and obtained a manufacturing license for her pharmacy in 1996. She was certified as a ‘Qualified Person’ in 1999. From 2000 to 2006 she worked as a project manager in the field of drug regulatory affairs and GMP for APIs (active pharmaceutical ingredients) with Concept Heidelberg, Germany. In 2006, she co-founded the regulatory affairs consultancy PhACT GmbH (Pharmaceutical Advice, Compliance and Training) in Switzerland. Within the Parenteral Drug Association (PDA) Barbara was a member of PDA’s Regulatory Affairs and Quality Advisory Board and served as the European co-chair of PDA’s Regulatory Affairs Interest Group. As an editor and co-author she published the second edition of a book titled regarding ‘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.