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Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance
Session Chair(s)
Samantha Roberts, PhD
Senior Director, Regulatory Intelligence
AstraZeneca, United States
This forum will address the implementation of innovative clinical trial designs. Specific examples will be discussed and regulatory efforts to foster innovation will be examined to identify opportunities to increase stakeholder understanding.
Learning Objective : Identify precedents and opportunities to adopt innovative trial designs in severe, chronic diseases; Describe and assess regulatory efforts to foster clinical trial innovation; Identify mechanisms to enhance public awareness regarding implementation of clinical trial innovation in drug development.
Speaker(s)
Industry Reflection
Rasika Kalamegham, PhD
Genentech, A Member of the Roche Group, United States
Head, US Regulatory Policy
Industry Reflection
Victoria A. Dohnal, RAC
Johnson & Johnson, United States
Director, Global Regulatory Policy and Intelligence
FDA Update
Representative Invited
FDA, United States
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