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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
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.
GUEST SPEAKER
Dr. Christoph Ortland
Forschungsdock CRO
Founder & CEO
Christoph has over 30 years of experience in clinical development, project management, clinical monitoring, and quality management. With more than 10 years as a GCP Auditor and over 20 years as a GCP Trainer, he brings extensive expertise in GCP compliance, auditing, and quality oversight, combined with a practical and structured approach to clinical research.
Appointments
- October 29, 2026, 4:00 PM - 5:00 PM
Expert Dialogue | Risk Proportionality in Clinical Trials: What Does It Mean in Practice?
Risk proportionality is becoming central to modern clinical trial quality management. Regulators encourage proportionate approaches, but many teams still struggle to translate the principle into practical oversight.
In this mindsON RBQM Expert Dialogue, Keith Dorricott and Christoph Ortland will discuss what risk proportionality means in clinical trials and how it can be applied beyond the trial risk assessment. The conversation will explore practical examples across:
• trial oversight
• TMF
• vendor management
• issue management
• CAPA
Rather than applying the same level of control everywhere, a risk-proportionate approach asks where additional oversight genuinely protects participant safety, data reliability, and trial integrity — and where it may create unnecessary burden.
This fireside-style discussion will also address why process-level thinking matters. Many quality risks do not sit within a single trial. They emerge through recurring processes, handoffs, vendor interfaces, and escalation pathways.
This session is relevant for clinical operations, QA, RBQM, TMF, vendor oversight, monitoring, issue management, and governance professionals.
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/
NEW | AI Essentials for Clinical Trials Certification: https://academycyntstg.wpengine.com/product/ai-essentials-for-clinical-trials/ (70min, self-paced e-course)