Meeting Highlights - June 19, 2006

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Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-19-2006, Volume 0, Issue 0

Welcome, Awards Presentation, Keynote Address and Hot Topics

June 19, 2006

08:30 am - 10:00 am

Welcome and Awards Presentation

Teresa K. Musser,

President, DIA,
Senior Director, Project Mgt. & Clinical Operations

Rigel Pharmaceuticals

Opening Remarks

Charles C. Depew, PharmD

2006 DIA Annual Meeting Chairperson,


Keynote Address


Sanjay Gupta, MD

Senior Medical Correspondent
Health and Medical Unit at CNN
Faculty, Department of Neurosurgery
Emory University School of Medicine

10:00 am - 6:00 pm — STUDENTS POSTER SESSION

10:30 am - 12:00 pm

Patient-reported Outcome Instruments:
Overview and Comments on the FDA Draft Guidance

Chairperson, Laurie Beth Burke,
Office of New Drugs, CDER, FDA

3:30 pm - 5:00 pm

Electronic Patient-reported Outcomes (ePRO) Technology and the
FDA Draft PRO Guidance: A Town Meeting to Discuss Industry's Response

Chairperson and Moderator: John M. Weiler, MD, President,

CompleWare Corp.

3:30 pm - 5:00 pm

Prescription Drug Labeling: Implementation of FDA's New Regulation for the Content and Format of the USPI and Accompanying Guidance Documents

Chairperson: Steven W. Bass, PhD, Group Director,
Global Labeling and Promotion Compliance,

Bristol-Myers Squibb Co.

5:00 pm - 6:00 pm

Exhibit Hall A, B, & C, 2nd Floor, Convention Center