mindsON RBQM | Episode 25: RBQM, RBM, QbD, CM, CSM - so many terms but what are they, and how do they relate to each other?

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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 Proeve 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.

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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.

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.

March 28, 2024 Susan Andersen

I really appreciated the way the webinar was structured, to provide the background, followed by working thru real world examples. I look forward to future sessions where we continue the example.

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.

Description

An area of much debate (and confusion) is the differences, similarities, and overlaps between Risk-Based Quality Management, Quality by Design, Centralized Monitoring, Centralized Statistical Monitoring, Remote Monitoring, and Risk-Based Monitoring. Or, in the alphabet soup of our industry, RBQM, QbD, CM, CSM, RM and RBM. At this workshop, our industry experts will provide their perspectives and get the perspectives of those in the audience. Is the industry settling on definitions for these terms, or will the confusion persist?


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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