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.

 

2024 Focus

 

Upcoming events


 

 

 


Upcoming Events

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

Urgent Meeting: Medical Statistician Apprenticeship Scheme

The UK government have recently announced that level 7 apprenticeships must be fully funded by the employer from January 2026, for any apprentice over the age of 21. With funding for MSc's at an all time low, and universities courses facing closures, the apprenticeship scheme remains as important as ever, as a tool to encourage new statisticians into our industry. In this dedicated meeting, Valerie Millar (chair of the apprenticeship scheme) will provide full updates on the government changes and seek feedback and ideas from employers, universities and apprentices on how to keep this scheme successfully running for many years to come.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

Latest Jobs

Principal Statistician - Labcorp

This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.