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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

Retired from Head International Liaison Office and Conferences, Executive Depart, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Dr. Peter Bachmann is a senior regulatory scientist with over 25 years of leadership at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany and deep expertise in EU and global regulatory harmonization. He served as Chair of CMDh, Member of the EMA Scientific Coordination Board, EU Network Data Board, and HMA, representing the EU in ICH and as Chair of IPRP. Currently a Board Member of DGRA, he holds a Ph.D. in Pharmaceutical Biology from the University of Würzburg and completed postdoctoral research in Japan and the UK. He lectures at the Universities of Bonn, Basel, and Copenhagen, and has received TOPRA Lifetime Membership, MEGRA Honorable Membership, DIA Fellowship, and the DIA Outstanding Contribution to Health Award

Christa  Wirthumer-Hoche, PHD

Christa Wirthumer-Hoche, PHD

Retired, 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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