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International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

This session will present on recent work to harmonize RWE guidelines globally. Ongoing efforts in international collaboration on ICH M14 and the ICH reflection paper will be highlighted.

Learning Objectives

Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Recognize how to evaluate gaps in RWE harmonization needs.

Chair

Stephanie Choi, PhD

Speaker

Barriers and enablers in international RWE harmonization
Nicole Mahoney, PhD

Comparison of RWE guidelines across regions
Rachele Hendricks-Sturrup, DrSc, MA, MSc

ICH Efforts in International RWE Harmonization
David Moeny, MPH, RPh


Speakers
avatar for Stephanie Choi

Stephanie Choi

Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States
Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
avatar for Nicole Mahoney

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States
Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →
DM

David Moeny

Acting Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER, FDA, United States
David Moeny is a pharmacist and pharmacoepidemiologist with experience in clinical pharmacy practice, public health, drug utilization, regulatory pharmacoepidemiology, and international collaborations. At FDA, he has worked in both drug utilization and epidemiology teams and as the... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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