Three Key Impacts Of ICH E6(R3) On RBQM And Oversight

This guidance ICH E6(R3) introduces significant updates impacting Risk-Based Quality Management (RBQM). John Sikora's presentation at Momentum’s annual GCP Inspection Readiness conference outlined the drafted guideline’s effect on clinical trial oversight and preparation. Key updates emphasize integrating a culture of quality from the start, through principles like Quality by Design, which advocates for early inclusion of quality representatives in protocol drafting to identify and mitigate risks. The guideline stresses identifying Critical to Quality factors early and applying proportional risk mitigation strategies. RBQM should be embedded from the beginning of trial design, with continuous risk monitoring and mitigation crucial for maintaining data integrity, patient safety, and inspection readiness. Effective RBQM requires thorough sponsor oversight across planning, design, conduct, analysis, and reporting phases to prevent issues and ensure trial success.