Annette Stemhagen, DrPH, FISPE

Annette Stemhagen, DrPH, FISPE

Senior Vice President, Safety, Epidemiology, Registries & Risk Management

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.

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. 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 postapproval. Further, Dr. Stemhagen has designed and evaluated risk assessment studies, including more than 50 regulatory-mandated long-term safety studies. She has also developed Risk Evaluation and Mitigation Strategies (REMS) risk minimization programs and risk management evaluation studies.

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 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 and is active in the Drug Information Association. In 2004, she was appointed as the industry representative to the FDA Drug Safety and Risk Management Advisory Committee.