Annette Stemhagen, DrPH, FISPE

Senior Vice President
Safety, Epidemiology, Registries and Risk Management

annette.stemhagen@unitedbiosource.com Annette Stemhagen

Annette Stemhagen, DrPH, FISPE, 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.

With 15 years in safety surveillance of pharmaceutical, biotech and vaccine products, Dr. Stemhagen has over 25 years of public health epidemiological research experience. Her specific expertise is in the design, implementation and analysis of epidemiologic studies, registries, large streamlined safety studies and actual use and observational studies for products in Phase IIIb and post approval. Further, Dr. Stemhagen has designed and evaluated risk assessment studies, including more than ten regulatory-mandated long-term safety studies. She has also developed risk intervention programs, risk management evaluation studies and Risk MAPS.

Active in the International Society for Pharmacoepidemiology and the Drug Information Association, she was appointed in 2004 as the industry representative to the FDA Drug Safety and Risk Management Advisory Committee.

She holds adjunct faculty appointments at both 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.

Dr. Stemhagen received her undergraduate degree from the University of Pennsylvania, and her Masters and Doctoral Degrees from the University of Pittsburgh Graduate School of Public Health in Epidemiology.