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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
Parexel, United States
Vice President, AI & Digital Policy, Real-World Research
Industry Perspective
Rose Purcell, JD, MA
Takeda, United States
Director, Global Regulatory Policy and Innovation
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