mindsON RBQM Workshop | Episode 36: Trial-level Risks - Should you use a KRI, a QTL or Acceptable Ranges?

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July 9, 2025, 3:00 PM - 4:00 PM

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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

Dr. Johann Proeve

Johann has over 40 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.

Keith Dorricott, MBB

Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the Avoca Quality Consortium, such as 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.

February 11, 2025 Lidia Turo

Thank you for the excellent webinar. The interactive and engaging presentation made this complex topic easier to understand. The practical examples and insights were very valuable. Thank you once again for organizing such a high-quality event. I look forward to future webinars!

May 13, 2025 Sindee Grossman

I love that different perspectives were provided by the presenters.

Appointments

July 9, 2025, 3:00 PM - 4:00 PM

Description

Should KRIs ever be used at the trial level or only QTLs? ICH E6(R3) introduces Acceptable Ranges at the trial level - what are those? Join our experts, Johann and Keith, discussing trial-level risk monitoring. Come along to share your views via polling and whiteboards or just to listen and learn.

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.

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