Harald Enzmann has experience in academic, corporate and regulatory settings. A physician by training (graduation 1985), he received his MD “summa cum laude” from the Karl Ruprechts University, Heidelberg, Germany. Subsequently, he worked as a postdoctoral fellow at the German Cancer Research Center in Heidelberg and at the Institute of Pharmacology and Toxicology at the University of Erlangen, Germany. In 1989, Harald Enzmann joined Bayer AG and worked on in vivo and in vitro cancer models. He continued the development of cancer models at the American Health Foundation in Valhalla, NY, USA in 1995 and 1996 and after his return to the Bayer Research Center in Wuppertal, Germany. From 2000 to 2002, he was head of the department of Rodent Studies and Genotoxicity with Bayer AG. In 2002, he joined the German Federal Institute for Drugs and Medical Devices (BfArM) and first as head of preclinical pharmacology and toxicology and since 2005 as head of licensing division 2 and responsible for the indications cancer, immunology, hematology, metabolism, gastrointestinal disorders, endocrinology and diagnostics. Since April 2016 he is head BfArM’s European and International Affairs. Harald Enzmann received the Award of the German Cancer Research Center for Outstanding Research in 1987 and the Animal Welfare Research Award of the German Ministry of Health in 1995. He received the Master of Science Degree for Experimental Pathology from the New York Medical College 1996, the title “Privatdozent” and the venia legendi in Experimental Pathology from the University of Heidelberg in 1999. At the University Duisburg-Essen he is Associate Lecturer for Pharmaceutical Medicine and member of the Examination Board. He is a fellow of the International Academy of Toxicologic Pathology, member of the European Society of Toxicological Pathology, of the Society of Toxicology and of the European Association for Cancer Research. Since 2005, Harald Enzmann has been German Delegate to the Committee for Human Medicinal Products (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMA) and since October 2016 vice chair of CHMP.