mindsON RBQM EWG Workshop | Revealed: Best Practices for RBQM Oversight

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Moderators

MyRBQM Academy by Cyntegrity

Targeted education helps clinical research teams embrace the implementation process and contribute to its success, ensuring your organization's RBQM strategy has the components it needs to meet regulatory expectations.

Established in 2019, Cyntegrity's MyRBQM® Academy, units first-level online education, comprehensive instructor-led training, and practical case study workshops. Learn more at: www.academy.cyntegrity.com

Johann Proeve, PhD

With 45+ years in biopharma, including VP Global Clinical Data Management at Bayer, Johann brings data-driven realism to make strategies executable. A sought-after industry speaker, he translates complex clinical research practices into workable models. He is a member of the mindsON RBQM Expert Working Group, contributing seasoned sponsor-side experience to its oversight deliverables.

Keith Dorricott, MBB

A Master Black Belt since 2007, Keith applies Lean Six Sigma to optimize clinical-trial workflows, reengineer processes, and drive performance metrics. A frequent speaker at SCOPE and the MCC Summit, he makes complex methodologies practical. He leads the mindsON RBQM Expert Working Group and facilitates Avoca Quality Consortium workstreams on Centralized Monitoring, eCOA, and Vendor Oversight.

June 26, 2024 Michal Helbin

A comprehensive approach to the management of risks in a clinical study. The platform is very well designed, it has been very well presented during the webinar. The platform is detailed but graphically appealing. It utilizes the smart risk categories as proposed by the TransCelerate Biopharma, uses some proprietary tools and knowledge as designed by the Cyntegrity and is easily scalable should any organization need to add more categories at any time. Its a product well done.

October 22, 2025 Naomi Bossman

I appreciate the expertise and interpersonal dynamic of the presenters/moderator, as well as, examples, lessons learned, exercises, and ability to learn from other's experiences. Big fan of Cyntegrity! Thank you for hosting these webinars.

November 12, 2025 Mary Banach

Thank you - This webinar was exactly what is needed in the CDM Community. Mary Banach Chair DIA CDM Community

Revealed: Best Practices for RBQM Oversight

Oversight is a core theme in ICH E6(R3), but many teams still ask: “How much is enough, and how do we make it practical?” The mindsON RBQM Expert Working Group has been exploring exactly that—drawing on where the industry is moving and on the real-world experience of its members.

Join Keith Dorricott and Dr. Johann Proeve to hear what the group has been working on, see early ideas for supporting RBQM oversight, and learn where you can access a free, ready-to-use resource. You’re welcome to take part via polling and whiteboards—or just listen in and bring the lessons back to your study teams.

More about the mindsON EWG: https://www.minds-on.org/
Join our group on LinkedIn: https://www.linkedin.com/groups/10088435/

ABOUT "mindsON RBQM" WORKSHOPS

The mindsON RBQM workshops provide practical, system-agnostic guidance on the challenges of implementing and executing Risk-Based Quality Management (RBQM) in day-to-day clinical trial operations. These sessions emphasize interactive dialogue and problem-solving, offering a collaborative space to share experiences, explore strategies, and tackle real-world challenges.

Rooted in Quality by Design (QbD) principles, mindsON RBQM focuses on concepts and strategies without being tied to any specific system. For those looking to see these principles applied through technology, the actON QbD series offers complementary workshops with live demonstrations of use cases powered by the MyRBQM Portal.

Whether you choose to participate or simply observe actively, mindsON RBQM provides the knowledge and tools you need to navigate RBQM implementation confidently and effectively.