Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|June 18, 2006
- Applied Clinical Trials-06-19-2006
- Volume 0
- Issue 0
Meeting Highlights - June 19, 2006
Welcome, Awards Presentation, Keynote Address and Hot Topics
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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,
GlaxoSmithKline
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Overview and Comments on the FDA Draft Guidance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
MONDAY RECEPTION
Exhibit Hall A, B, & C, 2nd Floor, Convention Center
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