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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, OSI, OC, 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)
FDA Perspective
Emily Gebbia, JD
FDA, United States
Associate Director for Regulatory Development, OSI, OC, CDER
Site Perspective
Grant Huang, PhD, MPH
VA Office of Research and Development, United States
Acting Chief Research and Development Officer
Industry Perspective
Robert DiCicco, PharmD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
MHRA Perspective
Jason Wakelin-Smith
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Expert GCP Inspector and Head of Compliance Expert Circle
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