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Opening Remarks and Session 6: Scientific Roundtable: ICH Efforts on Convergence and Harmonization of Real-World Data and Evidence
Session Chair(s)
Camille Jackson
Director, Regulatory Policy; Legal and Regulatory
Flatiron Health , United States
An interactive panel of global regulators and industry experts will share updates on ICH’s efforts to align terminology, protocols, and reporting standards for Real-World Evidence (RWE), including progress on guideline M14. The session will cover international collaboration through ICMRA, updates to ICH E6 R3 Annex 2, and new topic proposals. Attendees will participate in roundtable discussions to explore implementation challenges and share perspectives on the evolving global RWD/RWE landscape.
Learning Objective : - Identify current ICH initiatives focused on harmonizing terminology, protocols, and reporting standards for RWE, including M14, by the end of the session
- Summarize key updates from global regulators on ICMRA collaboration and ICH E6 R3 Annex 2 within the session timeframe
- Discuss regional implementation challenges and stakeholder perspectives on M14 through guided roundtable discussions during the session
Speaker(s)
Scientific Roundtable: ICH Efforts on Convergence and Harmonization of Real-World Data and Evidence
Gracy G Crane, PhD, MS
Roche, United Kingdom
Policy Lead
Speaker
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
Speaker
Robert Reynolds, DrSc, MSc, FISPE
GSK, United States
Vice President, Global Epidemiology, CMO, R&D
Speaker
Julie Schneider, PhD, MSc
Johnson & Johnson Innovative Medicines, United States
Senior Director, RWE and Reliance Policy
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