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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)
Case Studies
Lesley Wise, PhD, MSc
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Managing Director
Case Studies
Bill Richardson, MD
NDA Regulatory Science Ltd, United Kingdom
Medical Advisor