This session will provide a summary of the key operational and methodological issues facing the implementation of active surveillance in electronic health care data, drawing on lessons learned from the FDA's Sentinel Initiative and pilot project, Mini-Sentinel and the Observational Medical Outcomes Project (OMOP). Speakers will identify which approaches have been successful and the challenges that lie ahead. This session is hosted by the International Society for Pharmacoepidemiology (ISPE).

Learning Objectives:
Describe the use of distributed electronic health data networks for medical product safety surveillance in the US
Compare the utility of active surveillance methods with varying design parameters
Identify the operational challenges to implementing active surveillance within a pharmaceutical company's signal management system.