Live Webinar

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

Course Information

Course Type: Live Webinar
Course ID: LSP1421
Date: November 03, 2026
US Eastern Time: 11:00 AM EST
GMT: 4:00 PM GMT
Duration: 60 Minutes
Presenter: Nelle Stocquart

Registration Options

Date: November 03, 2026
US Eastern Time: 11:00 AM EST
GMT: 4:00 PM GMT
Duration: 60 Minutes

Individual Access: USD 290.00
Team Access (2–5 Attendees): USD 390.00
Team Access (6–10 Attendees): USD 490.00

About the Course

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).

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 Should Attend

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

Presenter

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.