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

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February 29, 2024, 4:00 PM - 5:00 PM
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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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Dr. Johann Proeve

Johann has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. 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.

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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.

March 22, 2023 Stacey Dudkowski

I always find the webinars to have great information and the presenters to be extremely knowledgeable, and this one was no different. I highly recommend the webinars to my colleagues.

September 11, 2023 Lauren Wendland

Excellent workshop. Thank you! The example of under-reporting AEs was particularly helpful as it is something we have been working to address. I am also very interested to start working with the DIGR approach.

January 20, 2024 Peter Marks

Excellent webinar. Thought-provoking presentation and discussions - as always. Great to have the insights from Johan and Keith.

Appointments

  • February 29, 2024, 4:00 PM - 5:00 PM

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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