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Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Session Chair(s)
Michael Torok, PHD
Vice President, Global Head of Quality Assurance Programs
Genentech, A Member of the Roche Group, United States
This forum will present: 1) HA expectations related to cross-functional QbD, 2) Specific examples will highlight the change need for traditional clinical trial functions to meet QbD requirements.
Learning Objective : Explain Health Authority (HA) expectations for cross-functional Quality by Design (QbD); Describe the current state of traditional clinical trial functions and the needed change in those functions to meet HA expectations for QbD.
Speaker(s)
Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Representative Invited
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Jennifer Emerson, MPH, RN, PMP
Boehringer Ingelheim, Germany
Head Quality Analytics & Risk Management
Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Representative Invited
FDA, United States
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