Education 1986 Medical Degree from Copenhagen University, the Faculty of Medicine 2007 Master Degree in Public Administration, Copenhagen Business School Clinical Experience During 12 years (1986-1998) she worked at university hospitals in the Copenhagen area, and in 1995 she became specialist in internal medicine. Her clinical experience covers a wide range of medical specialties, e.g. nephrology, endocrinology, haematology, cardiology and infectious diseases. Her research activities were primarily within the areas of haematology, immunology, nephrology and endocrinology. Regulatory Experience She joined the Danish regulatory authorities and the EU Pharmacovigilance Working Party in 1998. In 2002 she became member of the European Risk Management Strategy Facilitation Group. As of July 2012 she is member of the Pharmacovigilance Risk Assessment Committee. Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, cooperation with academia and communication to health care professionals and the public on drug safety concerns. She is strongly engaged in the establishment of an international Pharmacovigilance Diploma education, in cooperation with the Danish Association of Pharmaceutical Industry / Medicademy, both as member of the education steering committee, as course leader and speaker. In 2004 – 2008 she was a member of DIA Advisory Council for Europe.