NATIONAL MEDICINES AGENCY

With a background in both pharmacy and legal sciences and a PhD in pharmacy, I am a lecturer at the Faculty of Pharmacy in Bucharest, Romania (where among others I give an optional course in pharmaceutical law and regulatory affairs). I have worked for almost 15 years in the academic environment, as well as in industry and regulatory authorities (Romanian Ministry of Health, National Medicines Agency) in mid and top management positions: former Director general of the Pharmaceutical General Directorate (within the Romanian Ministry of Health), former Head of European Integration Service within the National Medicines Agency, former Director General and then Vicepresident of the National Medicines Agency (later reorganized as National Agency for Medicines and Medical Devices). Romanian CHMP and PDCO member for almost 4 years (plus an additional one as observer in CHMP), I have acted as rapporteur for a large number of PIPs. I have also been an active member of the Formulation Working..