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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)
Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda, United States
Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera
Presenting and Communicating Benefits and Risks for Medical Decision-Making: Innovative Visualization Methods
Lesley Wise, PhD, MSc
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Managing Director
Integrating Evidence Across Multiple Data Sources for Signal Analysis: A Demonstration
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
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