Benefit-Risk ESIG (BRESIG)


  • 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 attending the PSI Conference 2023 in Hammersmith, London. We look forward to seeing you there!

Join us at the Welcome Reception on Sunday evening June 11th and at our session “Small Steps Towards Patient Focused Benefit-Risk Assessment” on Monday June 12th (11:00 – 12:30)!

2023 Focus


Upcoming events


Small Steps Towards Patient Focused Benefit-Risk Assessment”

Monday June 12, 2023 (11:00 – 12:30) 

Chaired by Martin Gebel – Introduction to BRESIG and “re-launch” of BRESIG

Preference-based Benefit-Risk Assessment [Shahrul Mt-Isa]

Introduces what “preference-based benefit-risk assessment” (pBRA) means, why should we care, and how they characterise and frame BRA for a better transparency and accuracy

Benefit-Risk Assessment in Clinical Trials with Composite Endpoints [Ursula Garczarek]

Presents options for BR composite endpoints, encourages debates on their pros and cons, and discusses the role that they can play in the overall BRA in drug development

Sample Size Calculations for Discrete Choice Experiments in Pharmaceutical and Health Care Applications [Marco Boeri]

Presents technical aspects and shift focus thinking when determining the sample size in preference studies to overcome the challenges in recruiting a large number of patients


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