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Short Course: Introduction to Benefit-Risk (BR) Management
January 25, 2026 – 8:30AM – 12:00PM ET | In-Person
*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
In this short course, we aim to introduce the basic concepts of comparative BR management based on industry’s best practices and the CIOMS XII guidance document. BR assessment has become an integrated part of any regulatory decision making for the marketing approval of medicinal products, as no product can be approved nor maintained if the BR profile is unfavorable. Most thinking about BR assessments used to focus on post-approval activities, but over the last years the emphasis has been extending to the pre-approval phase. BR assessments should be performed in a transparent way, based on scientifically sound and robust evidence, as well as subjective value judgements.
Short Course: Global Convergence in Risk Management Guidance Driving New Innovation Opportunities
January 25, 2026 – 1:00 – 4:30PM ET | In-Person
*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*
The short course will review the current state of the art in REMS and aRMMs. It will describe how industry can respond proactively to recent convergence in guidance from FDA, EMA and CIOMS through new, more collaborative, ways of working. We will show how to build on the approaches to SBRA that were discussed in the morning session, to better align risk management objectives and the REMS lifecycle with the healthcare and real-world context to provide better support for patients and HCPs.
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DIA Membership not only offers exclusive meeting rates, but can help you connect with global influencers, uncover ways to deliver impactful change, and access new knowledge that keeps you on the cutting-edge of healthcare conversations. DIA will help open doors to new pathways towards leadership growth and expand your network to include global peers who support one another in real-time. Learn more about membership today