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Comparative Perspectives on Regulating AI in Drug Development: US Versus EU
Session Chair(s)
Jayne Ware, MPH, MSc
Senior Director, Global Regulatory Policy
Merck Sharp & Dohme LLC, United States
Explore US and EU AI drug regulation with experts from regulator, industry, and academic perspectives. Learn about principles, data privacy, transparency, and real-world examples. Gain insights into vital regulatory nuances.
Learning Objective : Describe the regulatory frameworks in the US and EU; Discuss the practical necessity of regulation in various AI-driven drug development scenarios.
Speaker(s)
EMA Update
Steffen Thirstrup, MD, PhD
European Medicines Agency, Netherlands
Chief Medical Officer
FDA Update
Tala Fakhouri, PhD, MPH
FDA, United States
Associate Director for Data Science and Artificial Intelligence, CDER
Industry Perspective
Rose Purcell, JD, MA
Takeda, United States
Director, Global Regulatory Policy and Innovation
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