Active Surveillance of Medical Product Use in the FDA’s Sentinel System: A Focus on Pediatric Populations

The presentation provides an overview of the Sentinel System and describes how the pediatric population is characterized within the Sentinel Distributed Database (SDD). It also provides a detailed look at Mother–Infant Linkages in the SDD and a review of select pediatric focused studies conducted within Sentinel. It was presented at the March ISPE Pediatrics Special Interest Group (SIG) Meeting.