TL31: The Impact of EU Post-Approval Safety Surveillance Studies (PASS)
*Charles L Liss, AstraZeneca Pharmaceuticals 

Keywords: Epidemiology, drug utilization, safety outcomes, off-label use

Post Approval Safety Surveillance (PASS) studies required by the EMA as a requirement for product approval are becoming more ubiquitous as the effect of recent legislation is being implemented. Extensive programs of PASS studies are being conducted and results submitted to all regulatory agencies including the FDA. This roundtable would, hopefully, provide some insight into the FDA's view of this data and provide a forum for representatives from various companies to share their experiences in meeting the EMA requirements.