Developments in Postmarketing Safety Surveillance of Medical Products: Reflections from the FDA Sentinel Innovation Center
Join us on Wednesday, January 28th for a Department of Epidemiology seminar featuring Dr. Rishi Desai discussing Developments in Postmarketing Safety Surveillance of Medical Products: Reflections from the FDA Sentinel Innovation Center.
Abstract: The U.S. Food and Drug Administration (FDA) Sentinel Initiative—launched in 2008 under the FDA Amendments Act as the first national active-surveillance system for medical-product safety—has grown from a proof-of-concept pilot into the nation’s flagship regulatory grade evidence generation engine for pressing drug safety questions. In 2019, the FDA the US Food and Drug Administration prioritized more extensive electronic health records (EHR) integration to the existing claims-based Sentinel Distributed Databases and methodological innovations leveraging cutting edge data science approaches. This talk will provide an overview of the progress made by Sentinel’s Innovation Center in various domains including data infrastructure, information extraction, computable phenotyping, and confounding adjustment. Exemplary case studies will be discussed to highlight challenges and opportunities in applying the methodological innovations to inferential studies of medication safety.
Bio: Rishi J Desai, MS, PhD, is an Associate Professor of Medicine at Harvard (HMS/HSPH) and an Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. His research focuses on understanding the use of medications and resulting outcomes in routine care patients with chronic diseases. He has a special interest in methodological investigations to improve inference from non-randomized studies of medication effects. He is currently the Operations Lead for the FDA Sentinel Innovation Center. His work has been funded by the National Institute on Aging, the National Heart, Lung, and Blood Institute, and the Food and Drug Administration. He has authored >185 original research publications.
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Rishi Desai, MS, PhD
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