DIA Workshop on Benefit-Risk Strategy

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Session 2: Implementing Benefit-Risk More Effectively

Session Chair(s)

Steffen Thirstrup, MD, PHD

Chief Medical Officer, European Medicines Agency, Netherlands

The session will walk you through the do's and don'ts of benefit-risk implementation. It will reflect a number of case studies that clarifies potential risk areas. The essential elements of the session are: - What benefit-risk information to include in the clinical overview - Choosing the right qualitative or quantitative framework

Speaker(s)

Lesley Wise, PHD, MSC

Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom

Case Studies

Bill Richardson, MD

Medical Advisor, Sagittal Pharma Consulting, United Kingdom