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Monday, June 17 • 2:15pm - 3:15pm
#139: Comparative Perspectives on Regulating AI in Drug Development: US Versus EU

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-539-L04-P; CME 1.00; RN 1.00

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 Objectives

Describe the regulatory frameworks in the US and EU; Discuss the practical necessity of regulation in various AI-driven drug development scenarios.

Chair

Jayne Ware, MPH, MSc

Speaker

EMA Update
Steffen Thirstrup, MD, PhD

FDA Update
Tala Fakhouri, PhD, MPH

Industry Perspective
Rose Purcell, JD, MA


Speakers
avatar for Jayne Ware

Jayne Ware

Senior Director, Global Regulatory Policy, Merck Sharp & Dohme LLC, United States
Jayne is Senior Director for regulatory policy and has been at Merck for over 12 years. She is a senior regulatory policy analyst, responsible for leading surveillance and advocacy on a variety of regulatory policy issues, including artificial intelligence, digital health technologies... Read More →
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, Office of Medic, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
avatar for Rose Purcell

Rose Purcell

Director, Global Regulatory Policy and Innovation, Takeda, United States
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session