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Medical Product Safety: Ten Years of the U.S. Sentinel System

    Basic Details

    This presentation discussed the creation of the U.S. Sentinel System, the data contained within it and how such data are curated, the FDA's use of the Sentinel System for safety/regulatory questions, methods development, and advances in the FDA-Catalyst program that supports studies that include patient interventions.

    The presentation was originally given as a webinar and is available for viewing. To access the webinar: 

    1. Navigate to the ISPE Webinar page here.
    2. Click on 'Register'. Users will be prompted to create an account. Materials are freely available once a user creates an account with ISPE. If you already have an account, select 'Log In'.
    3. Once registered, log in. The webinar will be available for viewing. 

    Sarah Dutcher, Judith C. Maro, David Martin