Current European Perspective in Structured Benefit-Risk Assessment

• Activity Number: 145
• Type: Contributed
• Date/Time: Monday, August 5, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Shihua Wen*+
• Companies: Abbvie
• Keywords: benefit-risk ; structured framework ; EMA ; decision-making

Abstract

New regulations and a rapidly evolving environment on assessing pharmaceutical benefit-risk have demanded the development of respective methods. Both sponsors and regulators have realized that an appropriate structured benefit-risk framework is needed for clear communication, structured discussion, and enhanced transparency and accountability. Beginning in 2008, a number of regulatory agencies from major European countries initiated the EMA Benefit-Risk Methodology Project to develop tools and processes for balancing multiple benefits and risks, which can be used as an aid to informed, science-based regulatory decisions on medicinal products. Up to today, 4 of five working packages (WPs) based on the outcome of this research project have been published, and this presentation will serve as a concise report on those WPs as well as an introduction of PrOACT-URL, the EMA adapted benefit-risk assessment framework. In addition, practical experience of using this PrOACT-URL framework will also be shared.