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Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
Session Chair(s)
Emily Gebbia, JD
Associate Director for Regulatory Development, OC, OSI, CDER, FDA, United States
This session will cover the different ways clinical trials can be operationalized in clinical care, the benefits and challenges of the various approaches, and the applicability of good clinical practice requirements to them.
Learning Objective : Describe key elements of the design and conduct of trials integrated into clinical care; Outline the various operational approaches for such trials, including the benefits and challenges; Discuss the applicability of good clinical practice requirements to various operational approaches.
Speaker(s)
Emily Gebbia, JD
Associate Director for Regulatory Development, OC, OSI, CDER, FDA, United States
FDA Perspective
Grant Huang, PHD, MPH
Acting Chief Research and Development Officer, VA Office of Research and Development, United States
Site Perspective
Robert DiCicco, PHARMD
Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Industry Perspective
Jason Wakelin-Smith
Expert GCP Inspector & Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
MHRA Perspective
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