Harnessing Big Data for Medical Product Safety Surveillance: The Experience of the Sentinel Initiative

The U.S. Food and Drug Administration's (FDA) Sentinel Initiative is a long term effort to improve the FDA’s ability to identify and assess medical product safety issues. The Sentinel System is an active surveillance system that uses routine querying tools and pre-existing electronic healthcare data from multiple sources to monitor the safety of regulated medical products. FDA-Catalyst activities leverage the Sentinel Infrastructure by utilizing the data available through its Data Partners and supplementing it with data from interventions or interactions with members and/or providers. The FDA uses these data for regulatory decision-making. This presentation discusses the core elements of the Sentinel System, will touch on select safety assessments within it, and new initiatives to improve the use of these data.

This syposium presentation was given at the Annual Meeting of the Réseau Québécois de Recherche sur les Médicaments (RQRM) in Montreal, Canada.