Mohamed Baccouche, PhD

Dr. Mohamed Baccouche is managing director of the Institute for Regulatory Affairs and Pharmaceutical Services (IPMB GmbH, Radolfzell Germany, www.ipmb.eu), a service provider for the pharmaceutical industry for the development and approval of drugs and medical devices.

Mohamed Baccouche has a 30 years experience in the pharmaceutical industry, where he has held several executive functions such as head of project management and head of clinical development. From1988-2007 Mohamed Baccouche was head of global Regulatory Affairs and Scientific Information at Byk Gulden and Altana Pharma. In this function he led a large global regulatory affairs team, being responsible for the regulatory strategy of newly developed products as well as life cycle management and regulatory maintenance of worldwide marketed products. His responsibility covered also the regulatory document management system with eCTD, the CMC Regulatory Affairs, The Regulatory Intelligence and the Scientific Information departments.

Mohamed Baccouche is co-founder of the German Society of Regulatory Affairs (DGRA) of which he acted as a member of the board and co-chairman for several years. Since 1999 Mohamed Baccouche has been a lecturer in Drug Regulatory Affairs and Good Regulatory Practices at the University of Bonn, Germany. He is a regular chairman and speaker at international regulatory conferences and has given and written numerous presentations/ publications in Regulatory Affairs. Since 2009 he is chairman of the European Society of Medical Device Regulations (SMDR) and member of the European Course of Medical Device Regulations (ECMDR).