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The FDA's Commitment to Patient-Centric Research: Key Themes from Decentralized Trial Draft Guidance
Session Chair(s)
Rasika Kalamegham, PhD
Head, US Regulatory Policy
Genentech, A Member of the Roche Group, United States
This interactive forum will explore the key themes and industry feedback from the decentralized trials alliance members’ response to the FDA draft guidance on decentralized clinical trials.
Learning Objective : Examine how the FDA draft guidance reflects a commitment to patient-centric decentralized clinical trials; Identify key themes and industry feedback provided in the alliance's response to the draft guidance; Discuss the next steps needed to enable adoption of decentralized trials under the draft framework.
Speaker(s)
Collaboration Perspective
Jane Elizabeth Myles, MSc
Decentralized Trials and Research Alliance, United States
Program Director
FDA Perspective
M. Khair ElZarrad, PhD, MPH
FDA, United States
Director, Office of Medical Policy, CDER
Industry Perspective
Dylan Bechtle, MS
Johnson & Johnson, United States
Associate Director, Regulatory Policy Lead- US
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