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Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development
Program Code:
303
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Barbara Leishman,
MA (SCHNON), External Business Alliance Leader,
F. Hoffmann-La Roche Ltd., Switzerland
Barbara has over 30 years experience in the pharmaceutical industry, primarily in clinical drug development. In Roche, she has been responsible for numerous regional and global regulatory submissions. She is currently responsible for external business alliances in Roche Clinical Quality
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SPEAKER
(S):
Barbara Leishman,
MA (SCHNON), External Business Alliance Leader,
F. Hoffmann-La Roche Ltd., Switzerland
Barbara has over 30 years experience in the pharmaceutical industry, primarily in clinical drug development. In Roche, she has been responsible for numerous regional and global regulatory submissions. She is currently responsible for quality risk management in safety science/pharmacovigilance
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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
Ken has 18 yrs experience in the industry, leading international teams in the development of NCEs and commercialization of drugs. He previously worked for 16 years as a pediatrician and pediatric cardiologist , then joined Bayer Healthcare (Levitra clinical lead) and Neurogen before Pfizer in 2009.
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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.