The Sentinel System— An Overview of FDA’s Tools for Assessing Medical Product Safety and Gathering Real-World Evidence

August 21, 2019 – This webinar provides an overview of Sentinel’s growing capabilities and value in regulatory decision-making. Sentinel enhances the FDA’s ability to proactively monitor the safety of medical products after they have reached the market and complements the Agency’s existing spontaneous reporting systems. Particular focus is on Sentinel’s role in safety surveillance and use of real-world data (RWD) and real-world evidence (RWE). The webinar also highlights the efforts and objectives of a patient representative-led stakeholder engagement work group that developed tailored messages for diverse audiences on the broadened uses of Sentinel.