Susanne Keitel

Company: EDQM

Susanne Keitel is a licensed pharmacist with a Ph.D. in pharmaceutical technology. Her work experience includes 10 years in pharmaceutical development in industry, with five years as Department Head of ”Pharmaceutical Development/Oral Dosage Forms“ at the former Schering AG, Berlin. From 1997 to 2005, she held the position of Division Head Pharmaceutical Quality at the Federal Institute for Drugs and Medical Devices (BfArM), Germany. She additionally served as Acting Head of the Division European Procedures from November 2003.

From July 2005 to October 2007, Susanne Keitel was Head of EU, International Affairs at BfArM. During her time with BfArM, she represented the agency in a number of EU committees, including the Joint CHMP/CVMP Quality Working Party (QWP), the EMEA Paediatric Working Party and the European Commission’s Notice to Applicants Group. She was actively involved in the International Conference on Harmonization (ICH), where she acted as the EU topic leader and rapporteur for the ICH guidelines on stability testing and pharmaceutical development. On a national level, she was from 2001 to 2007, Chair of the German Pharmacopoeia and the German Homeopathic Pharmacopoeia. Since October 2007, Susanne Keitel is Director of the European Directorate for the Quality of Medicine & HealthCare (EDQM) of the Council of Europe in Strasbourg.

She also lectures in the postgraduate course “Master of Drug Regulatory Affairs” at Bonn University, where she is responsible for the module on the quality dossier. In 2009, Dr. Keitel was elected as corresponding Foreign Member at the French Académie Nationale de Pharmacie.