The U.S. Food and Drug Administration (FDA) is pleased to announce the 10th Annual Sentinel Initiative Public Workshop scheduled for February 7th and 8th, 2018. The meeting will cover how Sentinel has impacted public health, advanced regulatory drug safety efforts and explore future directions for the program. Sentinel enhances FDA’s ability to proactively monitor the safety of medical products and complements the existing FDA Adverse Event Reporting System. Through Sentinel, FDA can rapidly and securely access information from large amounts of electronic healthcare data, such as electronic health records (EHR), insurance claims data and registries, from a diverse group of data partners. Sentinel uses a distributed data approach which allows the FDA to monitor the safety of regulated medical products, while securing and safeguarding patient privacy.
Day 1 of the meeting is scheduled for February 7, 2018 at the Hyatt Regency Hotel in Bethesda, MD, and will feature several presentations about Sentinel activities. Day 2 of the meeting is scheduled for February 8, 2018 at the FDA campus in White Oak and will feature a workshop on Sentinel tools and capabilities. Please note, there is a separate registration process for each meeting day and while registration is free, seating is limited so early registration is encouraged. A webcast option will also be available for both days. For more information on Sentinel see FDA’s recent CDER Conversation: The FDA Sentinel Initiative.