The U.S. Food and Drug Administration (FDA) today issued the “Sentinel 5-Year Strategic Plan: 2019-2023.”  This plan lays out the major goals associated with the future of the Sentinel System and FDA Catalyst. It is intended to serve as a roadmap to guide the development of Sentinel over the next five years. Specifically, the plan discusses five strategic aims. First, enhance and expand the Sentinel System’s foundation (i.e. data, infrastructure, operations, technology). Second, augment the Sentinel System’s safety analysis capabilities by leveraging advances in data sciences and signal detection. Third, leverage the Sentinel System to accelerate access to and broader use of Real-World Data (RWD) for Real-World Evidence (RWE) generation. Fourth, broaden the Sentinel System’s ecosystem of stakeholders to pursue the vision of a national resource. Finally, disseminate knowledge and advance regulatory science to encourage innovation and meet Agency scientific needs. 

 

The strategic plan will figure prominently at the next Annual Sentinel Public Workshop on April 3-5, 2019.  During this meeting FDA will share updates on how FDA plans to realize the vision in the Strategic Plan. This annual workshop is a gathering of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative, provide training on Sentinel System’s tools and data infrastructure, and promote engagement and collaboration with patients, industry and consumers. Please consider joining us for some portion this important workshop. 

 

For more information, please visit: Sentinel 5-Year Strategic Plan.