The U.S. Food and Drug Administration’s Sentinel System: A Post-Market Active Drug Safety Surveillance System

This presentation describes the Sentinel Initiative, highlighting its goals, implementation timeline, and key components. Established by the U.S. Food and Drug Administration (FDA) to ensure the safety, efficacy, and security of regulated medical products, the Sentinel System monitors the use and safety of these products post-market. Key components include the Sentinel Operations Center (SOC), Innovation Center (IC), and Community Building and Outreach Center (CBOC), which collectively maintain a comprehensive database, develop innovative analytic tools, and engage with the community to enhance drug safety surveillance and regulatory decision-making. It was presented at the 2024 ISPE: 4th Annual African Regional Interest Group Meeting.