Sentinel System Five-Year Strategy: 2019-2023

Project Title Sentinel System Five-Year Strategy: 2019-2023
Wednesday, January 9, 2019

To lay out the major goals associated with the future of the Sentinel System and FDA Catalyst, the FDA has released the Sentinel System Five-Year Strategy: 2019-2023. This plan is intended to serve as a roadmap to guide the development of the Sentinel System between 2019 and 2023. 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.


U.S. Food and Drug Administration

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