DIA 2013 49th Annual Meeting
Click here to go to the previous page
Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development
Track : Track 02: Project/Portfolio Management and Strategic Planning
Program Code: 303
Date: Wednesday, June 26, 2013
Time: 8:00 AM to 9:30 AM  EST
Location: 205B
CHAIR :
 Barbara Leishman, MA (SCHNON), External Business Alliance Leader, F. Hoffmann-La Roche Ltd., Switzerland
SPEAKER (S):
 Barbara Leishman, MA (SCHNON), External Business Alliance Leader, F. Hoffmann-La Roche Ltd., Switzerland
Mary Christian, PharmD (SPKNON), Executive Director, Global Regulatory Strategy, Bristol-Myers Squibb Company, United States
 Kenneth J. Sprenger, MD (SPKNON), Executive Director, Medicine Team Leader, Pfizer Inc, United States
Description
This session will highlight the value of a product life cycle approach to prospective quality optimization, as opposed to a study-by-study approach, and provide real life experience in the risk-based design and management of a product life cycle.