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 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.
ICH E8 (R1) encourages us to create “a culture that values and rewards critical thinking and open, proactive dialogue…”. Some are surprised that we need regulators to tell us to think critically. In this interactive session, after providing background, we will explore questions such as: What happens if critical thinking isn't used during RBQM? How can we encourage people to think critically as they define, prioritize, control, and manage risks? Does thinking critically mean we should throw out all those checklists? Do we need humans to work in an RBQM environment, or can't the machines/systems manage the risks for us?
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.