Author/s: Amir Sarayani, Chair, ISPE Benefit-Risk Management SIG
SIG Leadership Team: Gita Toyserkani (Co-Chair, Risk Management); Jian-Yu E (Co-Chair, Benefit-Risk); Yujia Li (Secretary); Priya Bahri (Immediate Past Chair)
Benefit–risk management lies at the heart of pharmacoepidemiology in practice. We apply epidemiologic methods to evaluate the benefits and risks of medical products in broad populations under real-world conditions and provide evidence for decisions on marketing authorizations, product information, risk minimization, communication and product lifecycle management. In recent years, the benefit–risk management field has continued to evolve. New real-world data sources, emerging methodologies, technological advancements, and stronger expectations for transparency and patient engagement are reshaping how we assess and manage benefit–risk across the product lifecycle.
Against this backdrop, we’re pleased to share an important update about our ISPE community: the Benefit-Risk Assessment, Communication and Evaluation (BRACE) Special Interest Group (SIG) has been rebranded as the “Benefit-Risk Management SIG.” This change reflects a more clarified remit as well—with the goal of making it easier for the broader ISPE community to understand what we do, and engage with our work.
Why was the name changed?
Founded in 2012, the BRACE SIG has provided an interactive forum for education, training, and collaboration in benefit–risk assessment, as well as communication, risk minimization, and their evaluation. Over time, members and stakeholders told us the long name and the acronym were cumbersome and sometimes unclear—in some cases leading to out-of-scope abstract submissions to our Annual Conference (ICPE)—so ISPE Board has accepted our proposal to rebranded it as the Benefit-Risk Management SIG.
The new name is intended to be concise, intuitive, and directly descriptive of what we do. It also aligns with how benefit–risk works in real settings: not as a one-time assessment, but as an ongoing, lifecycle activity that includes assessment, risk minimization, communication, evaluation, stakeholder engagement, and overall benefit-risk management.
What is the clarified remit of the SIG?
Along with the name change, we clarified the SIG’s scope to be inclusive of both traditional and emerging scientific domains that sit within the benefit-risk cycle including:
Our mission is to continue and enhance providing an interactive and collaborative forum for education, training, and development among ISPE members and non-members with an interest in benefit-risk management for medical products.
Our objectives emphasize promoting awareness at the intersection of pharmacoepidemiology and benefit-risk management; defining best practices; and advancing the field through tools and methods, applied examples, peer exchange, and common understanding and practice.
How the change was developed
This update was shaped through SIG discussion across August–October 2025 meetings and then ratified through an open call for comments via the SIG community forum on ISPE Exchange. The name change was subsequently approved by the ISPE Board of Directors in November 2025 and implemented across ISPE’s communications and systems.
Where to find us
Visit ISPE’s Special Interest Groups page to find Benefit-Risk Management (formerly BRACE), and join our community on ISPE Exchange:
An invitation to the ISPE community
Benefit-risk management is inherently multidisciplinary: it spans evidence generation, structured assessment frameworks, risk minimization strategies, real-world evaluation, communication, and meaningful incorporation of patient perspectives across the lifecycle. Our SIG is designed to be a practical home within ISPE for that full set of activities—whether your work focuses on methods, applied studies, regulatory science, patient preference, or implementation in real systems.
We invite you to engage with the SIG in any of the following ways:
Final remarks
Rebranding from BRACE to the Benefit-Risk Management SIG is ultimately about being more accessible to the ISPE community and more faithful to the breadth of the work our members already do. We look forward to welcoming new collaborators and to building an even more engaged, global community around benefit-risk management within ISPE.
