September 19 DSaRM Meeting Agenda

8:00 am – Introduction of Meeting – Shalini Jain, Executive Secretary,

Peter Gross, M.D., Chairman

DSaRM

8:15 am – Similarities in Drug Names – FDA’s Perspective – Jerry Phillips,

Office of Drug Safety

8:30 am – Industry’s Perspective of Trademark Review – Robert E. Lee, Jr.,

PhRMA, Lilly

8:40 am – Study Design Methods – Victor Raczkowski, M.D.,

Office of Drug Safety

8:55 am – Computer Analysis Tools – Bonnie Dorr, Ph.D.,

University of Maryland

9:25 am – Expert Committees – Rick Shangraw, Ph.D.,

Project Performance Corporation

9:55 am - Focus Groups – Nancy Kline Leidy, Ph.D.,

Medtap International

10:25 am – Break

10:30 am – Simulated Practice Environment -Tony Grasha, Ph.D.

University of Cincinnati

Kraig Schell, Ph.D.

Angelo State University

11:00 am – Field Testing –Sean Hennessy, Ph.D.,

University of Pennsylvania

11:30 am – Lunch

12:30 pm – Open Public Hearing

1:30 pm – DSaRM Discussion

4:30 pm - Adjourn