mindsON RBQM | Episode 28: Can you define KRIs to monitor key risks?

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October 23, 2024, 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 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.

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.

September 17, 2024 Stacey Dudkowski

I found this episode to have valuable information, and could apply it directly to my everyday role.

September 18, 2024 Hanlie Bester

I thoroughly enjoyed the 'mindsON RBQM Episode 27' webinar! Dr. Johann Proeve and Keith Dorricott provided valuable insights on selection of additional risk controls. The examples were well thought out, and I found the integration of LLM responses into the presentation particularly interesting. Looking forward to the next episode!

Appointments

October 23, 2024, 3:00 PM - 4:00 PM

Description

We will share a simplified example of a protocol outline, along with high-risk items that we want to reduce. How would you define KRIs to monitor the high-risk items? How would you determine the metric definition and thresholds? Will you get the same answers as our RBQM experts? Come along to take part - or just listen and learn.

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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