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Sheraton Boston Hotel

Aug 18, 2014 8:30 AM - Aug 19, 2014 5:15 PM

39 Dalton Street, , Boston, MA 02119 , USA

European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

Speakers

Peter  Bachmann

Peter Bachmann

Deputy-Head, European Union and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Peter Bachmann is acting as the German NtA Member, a Member of the European Union Network Data Board and the EU IDMP/SPOR Task Force, the HMA WG ‘Better Use of Medicines’/'ePI Task Force', the International Pharmaceutical Regulators Programme (IPRP) Management Committee, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He has studied biology and chemistry and has a PhD in Pharmaceutical Biology, University of Wuerzburg (Germany). Following a JSPS postdoctoral fellowship at Kyoto University and a DFG Fellowship at the Institute of Food Research Norwich/UK, he has worked at the Institute of Pharmaceutical Biology, TU Braunschweig/Germany, until he joined in 1999 the BfArM, Department of Drug Approval.

Christa  Wirthumer-Hoche, PhD

Christa Wirthumer-Hoche, PhD

Chair, EMA Management Board, Head, Austrian Medicines & Medical Devices Agency (AGES), Austria

Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices Agency. Christa is the elected Chair of the EMA Management Board.

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