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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)
ICH M4E (R2) Guideline: What’s New (and What’s Not)
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
The Changing Face of Benefit-Risk Assessments – Initiatives and Implications
Lesley Wise, PhD, MSc
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Managing Director
Benefit-Risk Assessment Evolution and Current Landscape
Steve Mayall, PhD
Huron Consulting Group, United Kingdom
Director