Third Annual Risk Management and Drug Safety Summit

One Registration - Washington, DC
Oct. 18-19, 2010 - Early Bird Fee


Conference Co-Chairs

Peter Pitts is co-founder and president of Center for Medicine in the Public Interest.  Prior to founding CMPI, Mr. Pitts was a senior fellow for healthcare studies at the Pacific Research Institute, a San Francisco based think tank.  From 2002-2004 he was the FDA’s associate commissioner for external relations, serving as the agency’s “chief messaging officer,” where his challenge was to clearly define the FDA’s brand image and to communicate the agency’s main themes to its many constituencies.

Annette Stemhagen, DrPH, FISPE, is the senior vice president of United BioSource's Epidemiology and Risk Management, where she provides strategic consultative services to pharmaceutical and biotechnology clients in epidemiology, safety surveillance and risk management. In addition, she assists other UBC groups in developing and implementing creative and innovative study design solutions to meet client needs. Dr. Stemhagen has more than 25 years of public health epidemiological research experience, including 15 years in safety surveillance of pharmaceutical, biotech and vaccine products.  Dr. Stemhagen received her undergraduate degree from the University of Pennsylvania, and her master’s and doctoral degrees from the University of Pittsburgh Graduate School of Public Health in epidemiology. She holds adjunct faculty appointments at the University of Pennsylvania School of Medicine Center for Epidemiology and Biostatistics and the Temple University School of Pharmacy. Dr. Stemhagen is a fellow of the International Society for Pharmacoepidemiology.

Distinguished FDA Representatives Special Presenter
Janet Woodcock
M.D., Director,
John Jenkins
M.D., Director, Office of New Drugs, CDER, FDA (invited)
Sir Alasdair Breckenridge
M.D., Chairman, Medicines and
Healthcare Products Regulatory Agency
Summit Faculty
Mark Ammann, Pharm.D., Vice President, Regulatory Affairs, United BioSource Corporation

Bob Anders, Pharm.D., Vice President, U.S. Processes & Systems, Lundbeck

Carmen Bozic, M.D., Vice President, Drug Safety & Risk Management, Biogen Idec

Kelly Davis, M.D., Vice President, Safety, Epidemiology & Risk Management, United BioSource Corporation

Gerald Faich, M.D., M.P.H., FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation

Edward Fotsch, M.D., CEO, PDR Network LLC
Gary Friedman, M.D., Medical Director, Novartis Pharmaceuticals

Patricia Fritz, Vice President,
Government Affairs and Policy, UCB, Inc. (invited)

Gordon Johnston, Vice President of Regulatory Sciences, Generic Pharmaceutical Association, former Deputy Director, Office of Generic Drugs, FDA (invited)

Christopher Pitcherella, External Provider Management Team Leader, AstraZeneca

Peter Pitts, Co-founder, President, Center for Medicine in the Public Interest, Partner/Director, Global Regulatory and Health Policy, Porter Novelli
Juergen Schmider, M.D., Ph.D.,
Corporate Safety Officer and Vice
President Global Pharmacovigilance
& Epidemiology, Cephalon

Annette Stemhagen, DrPH, FISPE, Senior Vice President, Safety, Epidemiology, Registries & Risk Management, United BioSource Corporation

Josephine Torrente, J.D., Director, Hyman, Phelps & McNamara, P.C.

Philippe van der Auwera, M.D., PhD., Global Head of Safety, Risk Management and European Qualified Person, F. Hoffman-La Roche AG