DIA 2013 49th Annual Meeting
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Quality Risk Management: An Old Hat?
Track : Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Program Code: 137
Date: Monday, June 24, 2013
Time: 2:30 PM to 4:00 PM  EST
Location: 156AB
CHAIR :
 Beat E. Widler, PhD (SCHNON), Managing Partner, Widler & Schiemann AG, Switzerland
SPEAKER (S):
Beat E. Widler, PhD (SPKNON), Managing Partner, Widler & Schiemann AG, Switzerland
 Brian J. Nugent, PhD (SPKNON), Associate Director, Clinical Operations, Gilead Sciences, Inc., United States
 Linda B. Sullivan, MBA (SPKNON), Vice President of Operations, Metrics Champion Consortium, United States
Description
A risk-based approach to quality management in clinical trials is the obvious solution. However, many sponsors of clinical trials have attempted it and failed. This session will show the essentials and examples of a successful implementation.