mindsON RBQM | Episode 22: Have QTLs been consigned to the trash can of history?

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Moderators

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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

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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 MCC, such as Centralized Monitoring, eCOA, and Vendor Oversight.

April 25, 2024 Philip Calvillo

Very helpful webinar to introduce me to the world of AI for use in Clinical research QRBM. This was very relevant, and Keith and Johann are the best! Thanks.

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.

June 27, 2024 Claudia Gruber

Great seminar building on previous sessions. Recapturing learnings. I enjoy these sessions, both Keith and Johann bring so much value to them supported by excellent material. Great engagement of the audience via polls and active collection of insights from participants. Time well spent - looking forward to the next episode after the summer break. Thanks!

Description

ICH E6 (R3) draft has replaced QTLs with "acceptable ranges." What does this mean? What happens to QTLs on studies where they've been set up? How should we go about setting up acceptable ranges?


ABOUT "mindsON RBQM" WORKSHOPS

mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialogue and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.

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