Innovative Methods for Evaluating Medical Product Safety and Effectiveness Using Real World Data: The U.S. Food and Drug Administration’s Sentinel Innovation Center

This poster describes the Sentinel Innovation Center (IC) of the U.S. Food and Drug Administration’s (FDA) Sentinel System. Established to assess drug use and safety, the Sentinel System functions through the Sentinel Operations Center (SOC), Innovation Center (IC), and Community Building and Outreach Center (CBOC). The IC focuses on developing and evaluating innovative methods for studying drug safety and effectiveness using real-world data (RWD). Key activities include leveraging novel data sources, real-world evidence innovation, advanced analytics, and informatics. This poster was presented at the 2024 ISPE: 4th Annual African Regional Interest Group Meeting.