Benefit-Risk SIG

The Benefit-Risk SIG was set up at the start of 2012 to help support those involved in this fast evolving area.

The main aims of the SIG are:

  • To understand how best to apply Benefit-Risk methodologies across the Pharmaceutical Industry
  • To discuss and make recommendations on key methodological issues
  • To share examples of how Benefit-Risk has been used within pharmaceutical companies
  • To share external information including new developments around Benefit-Risk

Currently the SIG has subgroups working on:

  • Literature review
  • Benefit-Risk in the HTA setting (together with the HTA SIG)
  • Bayesian applications in Benefit-Risk
  • Preference elicitation and  Benefit-Risk

We also develop relevant training in the area of structured  Benefit-Risk as needed.

If you have an interest in being involved in this SIG, or have an interesting case study or experience of carrying out a structured Benefit-Risk assessment to share, please contact Maria Costa (email: maria_j.costa@novartis.com)

Our BLOG can be found under www.benefit-risk-assessment.com. It is a great source of information for all things Benefit-Risk related: upcoming conferences, journal publications, training, and much more.

Upcoming Events

PSI Webinar: Risk Based Monitoring & QTL's

Since the introductio of ICH-E6 R2 Addendum sponsors must introduce formal Quality Risk Management and define Quality Tolerance Limits to their clnical development programs. This webinar will cover an introduction to those concepts, recent developments and examples of how companies are defining QTL's in practice.

PSI Webinar: Innovative approaches in the development of pediatric medicines

Do you want to learn more about innovative approaches for the development of pediatric medicines? Then join this PSI webinar on December 8. We have organized an exciting webinar with very knowledgeable speakers who will share their thoughts, ideas and experiences, including case studies, on a range of issues relating to historical data, Bayesian methodology, and partial and full extrapolation approaches in the context of developing pediatric medicines.

PSI Vaccine SIG Webinar: Some considerations on developing COVID-19 Vaccines

Statistical Observations on SARS-CoV-2 & Crisis Vaccine Clinical Testing. Scott Patterson, Bo Fu, Ya Meng, Fabrice Bailleux, Josh Chen.

PSI EIWG Webinar: PIONEERing estimands in Clinical Research

Bringing estimands to life through a real case study. Members of the estimands Implementation Working Group (EIWG) will describe the background and study objectives, intercurrent events of interest and chosen estimands in the PIONEER study.

PSI Medical Statistics Careers Event

Our annual PSI Medical Statistics Careers Event, will be held online using the Career Fair Plus app on Wednesday 3rd March 2021. The event will include a live online panel discussion and a virtual exhibition session.

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