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Session 7, Track B: Translating ICH E6(R3) into Action - Perspectives from Regulators, Sponsors, and Operational Teams
Session Chair(s)
Foo-Lim Yeh
Allergan Aesthetics, Neuroscience, and Specialty Head, Regulatory Affairs, AbbVie, Canada
Nessrine Hanna, MSc
Director, Clinical Operations, AbCellera, Canada
ICH E6(R3) represents an important shift toward a more flexible, risk-based approach to clinical trial quality, oversight, and data reliability. This session will bring together regulatory, sponsor, and operational perspectives to show how the new principles are being translated into practice across clinical trials. A key challenge for organizations is moving from traditional, retrospective compliance models to proactive, fit-for-purpose quality management and centralized oversight. The session will highlight practical solutions, including case examples, implementation strategies, and cross-functional collaboration to support participant protection and reliable trial outcomes.
Learning Objective : - Identify at least three key principles of ICH E6(R3) and explain how they affect clinical trial oversight, sponsor accountability, and quality management.
- Compare at least two perspectives—regulatory, sponsor, or operational—and determine one action they can apply in their own organization to support ICH E6(R3) readiness.
- Identify main implementation barriers to adopting ICH E6(R3) principles and propose one mitigation strategy for each
Speaker(s)
Kathy Heard, MSc
VP ClinOps and Safety, NoNO Inc, Canada
Case Study: Application of ICH e6(R3) Principles in Conducting Centralized Monitoring and Quality Review
Representative Invited
Country Clinical Operations Head, Clinical Site Management - Canada, AbbVie Corporation, Canada
Perspective from Clinical Trial Management/Industry