Michael Berntgen

Dr. Michael Berntgen is Head of the Scientific and Regulatory Management Department at the European Medicines Agency (EMA), London. This department manages the overall product lifecycle from initial marketing authorisation application onwards, covering the entire portfolio of products for clinical safety, efficacy and risk management activities, and maintaining the product oversight from therapeutic area perspective. Moreover, the Department is responsible for the management of the review of different aspects of labelling. He is a pharmacist by training and holds a PhD as well as a Master of Regulatory Affairs. From 1999 to 2006, Michael worked in various positions in regulatory affairs in the pharmaceutical industry in Germany and in the UK. In 2006 he joined the German national competent authority BfArM as Scientific Administrator in the Scientific Advice unit. Following this assignment he moved to the European Medicines Agency in 2007 where he initially took up a position as Scientific Administrator in the Therapeutic Group "Anti-infectives" of the Safety and Efficacy sector, followed in September 2009 by the assignment as Head of Rheumatology, Respiratory, Gastroenterology and Immunology in this sector. In September 2013 he took up his current responsibility for the Scientific and Regulatory Management Department.