12th Annual FDA Sentinel Public Workshop - Drug Information Update

12th Annual FDA Sentinel Public Workshop - Drug Information Update

The Food and Drug Administration (FDA), under cooperative agreement with the Robert J. Margolis, MD, Center for Health Policy at Duke University, is hosting the 12th annual Sentinel Initiative public workshop on April 20-21, 2020. This two-day, annual workshop is a gathering of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative, provide training on the Sentinel system’s tools and data infrastructure, and promote engagement and collaboration with patients, industry and consumers.

Day one of the public workshop, on April 20, 2020, will highlight recent achievements and strategic initiatives underway to enhance and build a more robust Sentinel Initiative and stakeholders will discuss opportunities to advance Sentinel’s existing data, infrastructure, and technology.

Day two, on April 21, 2020, will be organized into two separate workshops. The morning workshop will focus on the new Sentinel System Innovation Center and panelists will discuss methods and data needs to support new analytic techniques to improve the use of data in electronic health records. During the afternoon session, a public training for researchers, sponsored by the FDA and the Sentinel Operations Center will be held.

The Sentinel System is a national electronic system for medical product safety surveillance. Mandated by the FDA Amendments Act (FDAAA), the Sentinel Initiate established the system, in collaboration with public, academic, and private entities, as a method to obtain access to disparate data sources and validate methods to establish a system to link and analyze safety data from multiple sources. Sentinel has the largest multisite distributed database in the world dedicated to medical product safety.

For more information on the annual Sentinel Initiative workshop please visit the FDA Meetings, Conferences & Workshops (Drugs) webpage.