DIA Workshop on Benefit-Risk Strategy

Back to Agenda

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

Have an account?

DIA Workshop on Benefit-Risk Strategy

Session 1: ICH Guideline on Benefit-Risk Information

Session Chair(s)

Steve Mayall, PhD

Speaker(s)

ICH M4E (R2) Guideline: What’s New (and What’s Not)

The Changing Face of Benefit-Risk Assessments – Initiatives and Implications

Benefit-Risk Assessment Evolution and Current Landscape

Be informed and stay engaged.