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date_range October 23, 2025
⏰ Webinar Time: 11:00 – 12:30 (UTC+9, JST)
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Benefit-risk balance webinar – 2nd webinar
This webinar introduced and explained the main concepts of the CIOMS report on Benefit-risk balance for medicinal products.
About the event
- mic 5 Speakers
- group 1000 Places
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 introduced and explained the main concepts of the report.
Biographies: Download PDF
Recording Vimeo: https://vimeo.com/1133433121/13ac264ac3?share=copy&fl=sv&fe=ci
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
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Lembit Rägo
Secretary-General, CIOMS, Switzerland
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Graham Thompson
Regulatory Intelligence Director and Decision Analyst, AstraZeneca, USA
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Carmit Strauss
Executive Director, Head of Risk Management, Organ Toxicity and Benefit Risk, Takeda, USA, , Panel discussion
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Leo Plouffe
Vice President, Gilead Sciences, USA
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Stéphanie Tcherny-Lessenot
Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation, Sanofi, France
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Stewart Geary
Global Safety Officer, Eisai, Japan
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Claudia Ana Ianos
Safety Risk Lead, Pfizer, USA
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Shahrul Mt-Isa
Senior Director, BARDS HTA Statistics, MSD, Switzerland
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Scott Evans
Professor and Founding Chair, Department of Biostatistics and Bioinformatics Milken Institute School of Public Health, USA
Webinar programme
schedule All times shown in JST (Japan Standard Time, UTC+9)
Welcome and introduction
Lembit Rägo
Chapter 1: Benefit-risk landscape
Graham Thompson
Chapter 2. Structured benefit-risk approach/framework
Carmit Strauss
Chapter 3. Benefit-risk assessment methodology considerations
Leo Plouffe
Chapter 4. Specificities of benefit-risk assessment methods for special situations
Stéphanie Tcherny-Lessenot
Panel discussion
Claudia Ana Ianos, Scott Evans, Stewart Geary, Shahrul Mt-Isa, Leo Plouffe, Lembit Rägo, Carmit Strauss, Stéphanie Tcherny-Lessenot