Benefit-Risk ESIG (BRESIG)

Objectives

  • To understand and leverage Benefit-Risk methodologies for efficient and effective decision-making
  • To collaborate across industry, academia, and public bodies and across geographies to provide recommendations on key methodological issues across product life cycles
  • To increase use and acceptance of Benefit-Risk methodologies with case study examples
  • To disseminate external information to the broader community with conferences, workshops, seminars, and publications

Who are we

The Benefit-Risk ESIG was formed in 2012 with the vision to ensure industry professionals understood and effectively utilize Benefit-Risk methods throughout the entire medicinal product lifecycle process. The group is open to professionals from industry, academia, and public bodies (including regulatory and HTA agencies).

How to get in touch

We welcome new members and collaborators! Please reach out to Shahrul Mt-Isa or Marco Boeri if you have an interest in being involved in this ESIG, or have an interesting case study or experience of carrying out a structured Benefit-Risk assessment to share.

Latest news

We are delighted to share the news about the recent publication of the CIOMS Working Group XII report on Benefit-Risk Balance for Medicinal Products in May 2025.

This report provides insights into the methods used to evaluate the benefit-risk (BR) balance of a medicinal product. A favourable BR profile must be established for all medicinal products prior to marketing. This balance must be reassessed periodically in the post-marketing setting when new information regarding the benefits and risks, or the landscape of their application, becomes available. Two new points of emphasis include: (1) transitioning benefit-risk evaluation from a post-hoc exercise to a comprehensively integrated element of clinical trial design and conduct, and (2) a pragmatic patient-centric approach to benefit-risk assessment to ensure proper reflection and evaluation of the benefits and harms as experienced by patients. This report builds on the foundations of the CIOMS Working Group IV report published in 1998, and entitled: Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals; and expands to BR management throughout a product’s lifecycle using structured approaches and updated methodologies. Presentations on the report and its recommendations at various scientific conferences and webinar series are being planned and are subject to future communications.

 

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