The principles of Risk-Based Quality Management (RBQM) and Risk-Based Monitoring
(RBM) were introduced in the ICH E6 (R2) guidance several years ago and have been
strongly encouraged by regulatory bodies since 2011. This training will explore lessons learned, challenges, and best practices for remote and centralized monitoring in the context of the “new normal imposed on us during the current pandemic, as well as the longer-term implications for trial monitoring. The course will aim to discuss the perspective of sites, sponsors, and regulators.
Who should attend?
• Clinical operations personnel
• Quality personnel
• Clinical site staff
• Health Authority staff
• Clinical Project Managers
• Clinical Research Coordinators
• Drug Safety/Pharmacovigilance Staff
• Data Management
• Clinical Reserach Organizations (CROs)
• Service Providers (EDC, eCRF, etc.)