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.

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Future Events

ICH for Statisticians - Dates: 19 – 20 Nov, 2019

Course Summary: This course will give an overview of ICH guidelines for all statisticians in the setting of drug development trials and drug approval in the pharmaceutical industry.

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Impact of AI on Clinical Development - Dates: 11 – 11 Sep, 2019

In association with PSI, UCB and Cytel are delighted to invite you to join a symposium, educating on Artificial Intelligence (AI) approaches and their impact on clinical development.

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