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 VisSIG Wonderful Wednesdays

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.

PSI Book Club

PSI are starting a book club! We will be reading/discussing non-technical books relevant to our roles. Participants will be split into smaller groups to network with each other and practice exercises.

PSI Leading for Impact Workshop

Whatever your current challenge(s) at work, this workshop will explore what's holding you back, and how barriers can be removed in order to progress and achieve.

PSI Training Course: Repeated Measured and Mixed Models

A PSI Training Course covering the statistical methods for repeated measures and other clustered data. Course will cover: Conditional models for continuous hierarchical data, Conditional models for continuous longitudinal data, Marginal models (GEE) for continuous longitudinal data & Discrete data.

PSI Careers - Lunch & Learn: Imposter Syndrome Session

Learn from others in the PSI Community who also associate with Imposter Syndrome. They will discuss the topic, give their own personal views and experiences and provide tips to beat it.

Joint PSI, EFSPI & ASA BIOP Webinar: Complex Innovative Designs

Complex Innovative Designs: overview and case studies from FDA pilot program and considerations on master protocols.

PSI Training Course: R for Clinical Trial Statisticians

R is quickly gaining popularity within the pharmaceutical industry due to it being a very powerful object-orientated language, and is able to produce analyses and high quality graphics. This will be a hands-on interactive course and will utilise the RStudio Cloud development environment.

PSI Careers - MED MathS

In just 1 hour, learn about the field of medical statistics and how it plays a crucial role in developing ground-breaking new medicines, vaccines and healthcare products.

PSI Medical Statistics Careers Event

Our annual PSI Medical Statistics Careers Event, will be held online on Wednesday 2nd March 2022. The event will include a live online panel discussion and a virtual exhibition session.

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