CIOMS Benefit-risk balance webinar

place Online

date_range September 10, 2025

Benefit-risk balance webinar

This webinar introduces and explains the main concepts of the CIOMS report on Benefit-risk balance for medicinal products.

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About the event

  • mic 5 Speakers
  • group 2500 Places
  • import_contacts 1 Topics

In May 2025, the Council for International Organizations of Medical Sciences (CIOMS) published its consensus report on Benefit-risk balance for medicinal products. This webinar introduces and explains the main concepts of the report.

CIOMS consensus report: https://doi.org/10.56759/gwfz1791

A benefit-risk (BR) balance 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. This report provides insights into the current thinking and methods used to evaluate the BR balance of a medicinal product, and supersedes the report of the CIOMS Working Group IV, published in 1998, entitled: BR Balance for Marketed Drugs: Evaluating Safety Signals. The report defines and emphasises the need to use a structured framework for every BR assessment (BRA), and additional quantitative analysis to support structured BRA for more complex safety issues. This report presents new, key concepts for consideration when thinking about benefits and risks, including the need to take a lifecycle approach which considers knowledge gaps for products in early development as well as what is known about well-established products with extensive safety data.

Speakers and Panelists

  • Lembit Rägo

    Lembit Rägo

    Secretary-General, CIOMS, Switzerland

  • Graham Thompson

    Graham Thompson

    Regulatory Intelligence Director and Decision Analyst, AstraZeneca, USA

  • Carmit Strauss

    Carmit Strauss

    Executive Director, Head of Risk Management, Organ Toxicity and Benefit Risk, Takeda, USA

  • Leo Plouffe

    Leo Plouffe

    Vice President, Gilead Sciences, USA

  • Stéphanie Tcherny-Lessenot

    Stéphanie Tcherny-Lessenot

    Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation, Sanofi, France

  • Scott Evans

    Scott Evans

    Professor and Founding Chair, Department of Biostatistics and Bioinformatics Milken Institute School of Public Health, USA

  • Claudia Ana Ianos

    Claudia Ana Ianos

    Safety Risk Lead, Pfizer, USA

  • Shahrul Mt-Isa

    Shahrul Mt-Isa

    Senior Director, BARDS HTA Statistics, MSD, Switzerland

Webinar programme

Day 2025-09-10
14:00

Webinar programme

14:05

Chapter 1: Benefit-risk landscape

Graham Thompson

14:10

Chapter 2. Structured benefit-risk approach/frameowrk

Carmit Strauss

14:30

Chapter 3. Benefit-risk assessment methodology considerations

Leo Plouffe

14:45

Chapter 4. Specificities of benefit-risk assessment methods for special situations

Stéphanie Tcherny-Lessenot

Webinar has started

Registration Closed

The webinar registration is now closed. Please note that CIOMS will be hosting a second webinar on the same subject on the 23rd of October 2025 and details will follow shortly.