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:
- Navigate to the ISPE Webinar page here.
- 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'.
- Once registered, log in. The webinar will be available for viewing.
Sarah Dutcher, Judith C. Maro, David Martin