On June 12th, 2023, the CIOMS (Council for International Organizations of Medical Sciences) Working Group XII1 published a draft guideline on Benefit-Risk Balance for Medicinal Products for Public Consultation, which the BRESIG took the opportunity to review. We successfully submitted our feedback by the deadline of July 24th, 2023.
The long-awaited guideline is close to the BRESIG’s heart as it covers a variety of topics discussed within the group, and is central to our work within the (bio-)pharmaceutical industry. CIOMS guidelines are often cited and form the basis of many ICH (International Council for Harmonisation) guidelines.2
We are looking very much forward to finalization of this guideline because it provides an excellent overview of the elements of benefit-risk assessment that have been discussed in recent years in the literature and among practitioners. Therefore it is a perfect read for people newly interested but also for those following up on the topic. Notably valuable is a section including case studies.