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.cyntegrity.com
Johann Proeve 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.
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.
We are required to implement a risk-based approach to quality management (RBQM) for clinical trials. The process has changed significantly from the traditional model of regular on-site monitoring visits. In this interactive session, after providing background, we will explore questions such as: How do you know if the process is working as you expected it to? How do you know if RBQM is having an impact? Should RBQM be able to control all risks, or should we also expect the unexpected? What other options are available to manage the unknown risks?
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.