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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
Cyntegrity
Chief Scientific Officer
With 45+ years in biopharma, including serving as 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
Cyntegrity
Lead Instructor
A Master Black Belt since 2007, Keith applies Lean Six Sigma to optimize clinical trial workflows, reengineer processes, and improve performance metrics. A frequent speaker at SCOPE and the MCC Summit, he makes complex methodologies practical. Keith leads the mindsON RBQM Expert Working Group.
Appointments
- November 12, 2026, 4:00 PM - 5:00 PM
Detecting Issues in RBQM: Using What Goes Wrong to Drive Continuous Improvement
Issues such as protocol deviations are often treated as events to be managed, tracked, and closed. In RBQM, they should also be used as learning signals.
This session will explore how different types of emerging issues can be detected, understood, and used to reduce risk through improved mitigations and oversight. We will discuss how teams can distinguish isolated events from meaningful trends, identify potential systemic concerns, update the monitoring focus as needed, and create a traceable link among what is observed, what is reviewed, and what changes as a result.
The focus is not only on issue management, but on using issues to improve risk management, strengthen oversight decisions, and support continuous improvement in clinical trial conduct.
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 system-agnostic concepts and strategies. 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 observe actively, mindsON RBQM provides the knowledge and tools you need to navigate RBQM implementation confidently and effectively.
More about the mindsON Expert Working Group: https://www.minds-on.org/
Join our group on LinkedIn: https://www.linkedin.com/groups/10088435/
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