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Session 8: Advances in Benefit-Risk
Session Chair(s)
Elizabeth E. Garrard, PharmD
Executive Vice President, Global Safety Operations , Clinipace Worldwide, United States
Benefit risk evaluation is key to decision-making for most stakeholders involved with innovative medicines. Whereas regulators evaluate it at a population based level, healthcare professionals and patients need to understand how it affects them at the individual level: “Is drug A the right treatment for me/my patient?” This session will explore different measures for looking at benefit risk and new ways in which the data can be visualized to facilitate decision making. A system which helps integrate evidence across different data sources for signal analysis will be demonstrated.
Speaker(s)
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Vice President, Global Head of Medical Safety, Marketed Products and PDT, PSPV, Takeda Pharmaceuticals, United States
Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement
Lesley Wise, PhD, MSc
Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Presenting and Communicating Benefits and Risks for Medical Decision-Making: Innovative Visualization Methods
Mick Foy
Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Integrating Evidence Across Multiple Data Sources for Signal Analysis: A Demonstration
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