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Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective
Session Chair(s)
Kenneth Getz, MBA
Tufts Center for the Study of Drug Development
Tufts University School of Medicine, United States
This session will discuss regulatory and industry perspectives on building quality into clinical trials by providing updates to agency policy of risk-based monitoring (RBM), quality risk management (QRM), and quality-by-design (QbD) (e.g., ICH E6R3, ICH E8R1, draft and final guidances), including case examples.
Learning Objective : Discuss the importance of building quality into clinical trials; Identify a study’s critical quality (CTQ) factors and the importance of involving all stakeholders in their identification; Describe FDA’s expectations for implementing quality-risk management and developing and executing risk-based monitoring plans to focus on CTQ factors with inspection case examples of sponsors, CROs, service providers and clinical investigators.
Speaker(s)
Speaker
Linda B Sullivan, MBA
Tufts Center For the Study of Drug Development, United States
Senior Fellow
FDA Update
Elena Boley, MD, MBA, FACP
FDA, United States
Senior Physician, OSI, OC, CDER
Industry Update
Michael Torok, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Quality Assurance Programs
FDA Update
Cheryl Grandinetti, PharmD
FDA, United States
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
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