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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
Chief Medical Officer, European Medicines Agency, Netherlands
FDA Update
Tala Fakhouri, PhD, MPH
Chief AI & Regulatory Strategy Officer, Parexel, United States
Industry Perspective
Rose Purcell, JD, MA
Director, Global Regulatory Policy and Innovation , Takeda, United States
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