mindsON RBQM | Episode 33: The NEW mindsON RBQM Expert Work Group
Since their launch, our mindsON RBQM workshops have hosted over 30 sessions, engaging a dedicated community of professionals across the clinical trial landscape. By focusing on real-world challenges in implementing and advancing Risk-Based Quality Management (RBQM), these workshops have become a trusted space for collaboration and knowledge exchange.
We are excited to take this initiative to the next level by forming a dedicated Expert Working Group. This group will meet regularly to develop practical RBQM resources that address industry needs and keep pace with key developments, including the adoption of the ICH E6(R3) guidelines.
Why Now?
The recent adoption of the ICH E6(R3) guidelines signals a major shift in expectations around clinical trial design and execution, placing greater emphasis on proactive quality measures and efficient data oversight. With clearer definitions of roles, enhanced ethical safeguards, and an openness to innovative approaches like decentralized elements, the industry is entering an essential phase for risk-based practices.
Additionally, industry reports continue to highlight the effectiveness of centralized monitoring in improving patient safety and study oversight. Implementing streamlined, risk-focused processes helps sponsors and CROs transition smoothly while avoiding unnecessary complexity at the site level.
Since 2019, our workshops have connected us with thousands of professionals who have shared their insights, frustrations, and successes. This collective experience will inform the Expert Work Group’s direction as we shape actionable outputs that simplify processes and foster stronger stakeholder collaboration.
Your voice is welcome whether you’re a seasoned RBQM leader or simply passionate about making an impact. Join us at this session and help define the future of RBQM.
