Risk Based Quality Management and Risk Based Monitoring under ICH E6 (R3)

Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) are closely connected within modern clinical trial management, but their distinct purposes can create confusion during implementation. ICH E8(R1) introduces Quality by Design and a risk-proportionate approach to clinical studies, while ICH E6(R3) addresses the application of these principles within Good Clinical Practice. Understanding this relationship is important for determining how quality considerations and monitoring activities should be approached throughout clinical studies.

This webinar examines the principles of RBQM, their relationship with RBM, and the practical implications of both guidelines. Participants will consider how Critical to Quality factors are identified, what a risk-proportionate approach means, and how Quality by Design influences clinical study planning. The discussion also addresses the RBM requirements of ICH E6(R3) and the steps involved in implementing RBQM within an organization, providing a clearer basis for applying these related approaches in clinical research operations.