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Session 2: Implementing Benefit-Risk More Effectively
Session Chair(s)
Steffen Thirstrup, MD
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
Case Studies
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