In May 2025, the Council for International Organizations of Medical Sciences (CIOMS) published its consensus report on Benefit-risk balance for medicinal products. This webinar introduces and explains the main concepts of the report.

CIOMS consensus report: https://doi.org/10.56759/gwfz1791

A benefit-risk (BR) balance 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. This report
provides insights into the current thinking and methods used to evaluate the BR balance of a medicinal
product, and supersedes the report of the CIOMS Working Group IV, published in 1998, entitled:
BR Balance for Marketed Drugs: Evaluating Safety Signals. The report defines and emphasises the need to use a structured framework for every BR assessment
(BRA), and additional quantitative analysis to support structured BRA for more complex safety issues.

This report presents new, key concepts for consideration when thinking about benefits and risks,
including the need to take a lifecycle approach which considers knowledge gaps for products in early
development as well as what is known about well-established products with extensive safety data.