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International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers
Session Chair(s)
Stephanie Choi, PHD
Director, US Global Regulatory and Scientific Policy (GRASP)
EMD Serono, United States
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 Objective : Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Recognize how to evaluate gaps in RWE harmonization needs.
Speaker(s)
An Overview of Emerging Regulatory Guidance & Frameworks for Developing Fit-for-Purpose Real-World Evidence: Proposed Areas for Harmonization
Rachele Hendricks-Sturrup, DRSC, MA, MSC
Duke-Margolis Institute For Health Policy, United States
Research Director, Real-World Evidence
ICH M14: Establishment of an ICH guideline on “General principles on the plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines”
David Moeny, MPH, RPH
FDA, United States
Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER
Collaborative international efforts on RWD/RWE: What is coming next?
Patrice Verpillat, DrMed, MD, PHD, MPH
European Medicines Agency, Netherlands
Head of Real World Evidence
Opportunities for regulatory alignment? Data quality assessment and reporting
Nicole Mahoney, PHD
Novartis, United States
Executive Director US Regulatory Policy & Intelligence
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