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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 45 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
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.
Description
When designing a Key Risk Indicator (KRI), many considerations must be made, such as where the data is coming from, how often it's refreshed, whether the KRI is closely related to a risk, when to kick it off, and whether there will be too many false positives or negatives. Join our experts, Johann and Keith, as they discuss these challenges. Come along to share your views via polling, 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.