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Stop Moving the Goalposts: A Life Cycle Approach to Risk-based Quality Management in Clinical Development
Session Chair(s)
Barbara Leishman
F. Hoffmann-La Roche Ltd., Switzerland
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.
Learning Objective : Describe how to apply risk-based approaches in the clinical life cycle; Recognize the value of systematic, project-wide implementation of risk-based strategies; Identify techniques and tools to apply Quality by Design in designing and running clinical development programs.
Speaker(s)
Integrated QRM Across the Clinical Development Life Cycle
Kenneth J. Sprenger, MD
Pfizer Inc, United States
Executive Director, Medicine Team Leader
Regulatory Life Cycle Management: A Risk-based Approach
Mary Christian, PharmD, MBA
Lyndra Therapeutics, United States
Senior Vice President, Regulatory
Planning and Managing the Safety Life Cycle of a Product: A Risk-based Approach to Quality
Barbara Leishman
F. Hoffmann-La Roche Ltd., Switzerland
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