AIMS SIG - Open-Source Lunch Bites
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.
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).
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.
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.