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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
Guest Speaker: Miguel Valenzuela
Associate Director,
Clinical Risk & Analytics
(Alnylam Pharmaceuticals)
Miguel Valenzuela
Associate Director,
Clinical Risk & Analytics
(Alnylam Pharmaceuticals)
Miguel has been working in the industry for over 20 years in various capacities in informatics, Clinical Operations, Data Sciences, and Quality Assurance. In his earlier roles at Bayer and Roche, Miguel has led Quality Risk Management, Risk-Based Monitoring, and analytics driven oversight and continuous improvement groups and programs.
Since joining Alnylam in 2019, Miguel, while in GCP Quality Assurance, led the development and implementation of the Risk-Based Quality Management (RBQM+) approach and system in the organization.
Currently, he is the Associate Director Clinical Risk & Analytics, heading up the implementation of the RBQM process and systems and the buildup of the supporting group across Alnylam.
Dr. Johann Proeve
Chief Scientific Officer (Cyntegrity)
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
We will highlight the difference between a signal generated by an RBQM system vs an issue. Who should act, how, and on what kind of signal? Which signals can be ignored, which ones may require a follow-up, and which ones need urgent attention since they are not a signal anymore but already an issue? How will any actions and no-action-required decisions be documented for future reference? What should be kept at the end of a study to demonstrate a proper signal and issue management?
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.