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Session 1: ICH Guideline on Benefit-Risk Information
Session Chair(s)
Steve Mayall, PHD
Director, Huron Consulting Group, United Kingdom
This session will explain the recent changes in the ICH guideline on benefit-risk assessment, placed in the context of other benefit-risk initiatives. The session will address: - Updated ICH M4E (R2) guideline - Benefit-risk assessment evolution over the past several years - Impact of structured benefit-risk assessment on stakeholders
Speaker(s)
Francesco Pignatti, MD
Scientific Adviser for Oncology, European Medicines Agency, Netherlands
ICH M4E (R2) Guideline: What’s New (and What’s Not)
Lesley Wise, PHD, MSC
Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
The Changing Face of Benefit-Risk Assessments – Initiatives and Implications
Steve Mayall, PHD
Director, Huron Consulting Group, United Kingdom
Benefit-Risk Assessment Evolution and Current Landscape
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