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Hotel Grand Majestic Plaza

Jun 15, 2017 8:15 AM - Jun 16, 2017 5:00 PM

Truhlarska 16, 110 00 Prague 1, Czech Republic

DIA Workshop on Benefit-Risk Strategy

Session 1: ICH Guideline on Benefit-Risk Information

Session Chair(s)

Steve  Mayall, PhD

Steve Mayall, PhD


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


Francesco  Pignatti, MD

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

Francesco Pignatti, MD

European Medicines Agency, Netherlands

Scientific Adviser for Oncology

Lesley  Wise, PhD, MSc

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

Lesley Wise, PhD, MSc

Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom

Managing Director

Steve  Mayall, PhD

Benefit-Risk Assessment Evolution and Current Landscape

Steve Mayall, PhD

Huron Consulting Group, United Kingdom


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