1. Parallel Session 1 The Role of the Statistician in Post- Marketing, Including Surveillance Organizers –Harry Bushar (FDA-CDRH) –Greg Campbell (FDA-CDRH) –Gosford Aki Sawyerr (Purdue-Pharma, L.P.) Moderators –Harry Bushar & Gosford Aki Sawyerr

2. Session Objectives Provide insight into the role of the statistician in FDA post-marketing activities, medical device trials and pharmaceutical post-marketing activities Challenge statisticians to be prepared to widen their sphere of influence from traditionally accepted roles

3. Agenda 8:20: Danica Marinac-Dabic, MD, PhD (Chief, Epidemiology Branch, OSB, CDRH) –CDRH Postmarket Transformation and the Role of the Statistician 8:40: Andy Mugglin, PhD (University of Minnesota) –Statisticians in Medical Device Post-Market Studies 9:00: Larry Gould, PhD (Merck Research Labs) –Statistical Considerations in Postmarketing Safety Evaluation 9:20: Discussant: Jay Herson, PhD (Johns Hopkins University)