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What is happening at Global Pharmacovigilance and Risk Management Strategies Conference

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Provide actionable insights on evolving pharmacovigilance and risk management strategies across global regulatory landscapes
Highlight real-world applications of advanced technologies such as AI, ML, and real-world data in safety and signal management
Facilitate regulatory-to-industry dialogue on risk communication, safety assessments, and benefit-risk evaluations
Equip attendees with the tools to navigate the latest REMS and aRMM guidance and implementation frameworks, including CIOMS XII and the FDA REMS Logic Model

Network with global pharmacovigilance leaders across regulatory agencies, large pharma, small biotech, and public health foundations
Hear directly from FDA, EMA, MHRA, and other global regulators about the latest policies, guidance, and structural shifts in safety and surveillance
Engage in case-based discussions around REMS, signal detection, predictive technologies, and the application of real-world evidence in safety monitoring
Participate in interactive short courses on risk management convergence and benefit-risk planning aligned with CIOMS XII
Explore global and regional regulatory updates in Asia, Africa, Europe, and the Middle East in a dedicated session

Session 1: Fireside Chat with Dr. Robert Califf

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.

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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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