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

This course helps clinical trial teams distinguish RBQM from RBM, identify Critical to Quality factors, and establish a practical implementation approach aligned with ICH E8(R1) and ICH E6(R3).

WHY YOU SHOULD ATTEND:

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.

KEY  AREAS  COVERED:

• ICH E8(R1) principles for Risk-Based Quality Management
• ICH E6(R3) requirements for Risk-Based Monitoring
• Differences and relationships between RBQM and RBM
• Quality by Design in clinical studies
• Identification of Critical to Quality factors
• Risk-proportionate approaches and RBQM implementation steps
  
  

WHO  MUST  ATTEND :

• Clinical Operations Departments
• Quality Assurance Departments
• Data Management Departments
• Clinical Project Managers
• Clinical Operations Managers
• Biostatisticians
• Clinical Trial Managers

SPEAKER : Nelle Stocquart

Nelle Stocquart has worked in clinical research since 2003, beginning in IVRS project management before becoming a Clinical Research Associate and subsequently managing clinical studies for CROs and pharmaceutical companies. Her experience spans international Phase I through Phase IV studies, clinical project management, and team leadership, supporting the practical implementation of risk-based approaches in clinical research operations.