Current safety management practices are largely centered on the review and analysis of spontaneous adverse events reported by healthcare professionals, caregivers and patients. While existing processes have been instrumental in identifying new unsuspected safety concerns in the past, the availability of longitudinal real world data and modern digital technologies offers a new paradigm in enhancing knowledge of drug safety. Through the Sentinel Initiative, the FDA has built a robust system for gleaning intelligence from real world data. The FDA is now actively using the Sentinel System and Active Risk Identification and Analysis (ARIA) system to review safety concerns for several drugs.
This on-demand presentation is designed to help professionals in the field of Pharmacovigilance, Epidemiology and Medical Affairs to understand how they can harness the power of active safety surveillance for themselves.
- Dr. Judith Maro, PhD, Assistant Professor in the Department of Population Medicine, Harvard Medical School and the Harvard Pilgrim Health Care Institute
- Dr. Carla Rodriguez-Watson, PhD, MPH, IMEDS Scientific Director, Reagan-Udall Foundation for the FDA
- Ramprasad Keshavamurthy, MBA, Sr. Director of Life Sciences Solutions, Saama Technologies