Risk-based quality management (RBQM) is a fundamental component of modern clinical trial oversight, emphasized in ICH E6(R3) and FDA expectations. Traditional trial monitoring approaches often relied on extensive source data verification (SDV), but regulators now advocate for a proactive, risk-based approach that prioritizes critical-to-quality (CtQ) factors. This shift allows sponsors and investigators to focus resources on areas of greatest risk to patient safety, data reliability, and protocol compliance.
Effective risk management begins with early risk identification and assessment, utilizing methodologies such as Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA). Centralized and technology-driven monitoring further supports real-time risk mitigation, reducing inefficiencies while maintaining regulatory compliance.
This 60-minute webinar will provide a comprehensive overview of the evolving regulatory landscape under ICH E6(R3) and FDA expectations for risk-based quality management (RBQM). Participants will explore the key updates from ICH E6(R2) to ICH E6(R3), focusing on enhanced risk assessment, data integrity, and patient safety measures. The session will cover practical strategies for risk identification, evaluation, and mitigation, incorporating advanced digital tools and centralized monitoring approaches. Real-world case studies will illustrate implementation challenges, solutions, and best practices to enhance trial success and compliance.
Effective risk management begins with early risk identification and assessment, utilizing methodologies such as Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA). Centralized and technology-driven monitoring further supports real-time risk mitigation, reducing inefficiencies while maintaining regulatory compliance.
This 60-minute webinar will provide a comprehensive overview of the evolving regulatory landscape under ICH E6(R3) and FDA expectations for risk-based quality management (RBQM). Participants will explore the key updates from ICH E6(R2) to ICH E6(R3), focusing on enhanced risk assessment, data integrity, and patient safety measures. The session will cover practical strategies for risk identification, evaluation, and mitigation, incorporating advanced digital tools and centralized monitoring approaches. Real-world case studies will illustrate implementation challenges, solutions, and best practices to enhance trial success and compliance.
Why You Should Attend:
This training is essential for clinical research professionals seeking to stay ahead in the evolving regulatory landscape of ICH E6(R3) and FDA expectations for RBQM. Participants will gain practical insights into proactive risk strategies to enhance trial efficiency and compliance. With increasing emphasis on patient safety, data integrity, and digital monitoring, this session equips you with the knowledge and tools to implement risk-based approaches aligned with global regulatory demands.Speaker
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.Who Should Attend
- Clinical Trial Managers
- Clinical Research Associates (CRAs)
- Clinical Project Managers
- Quality Assurance (QA) Professionals
- Regulatory Affairs Specialists
- Principal Investigators (PIs)
- Study Coordinators
- Medical Monitors
- Data Managers
- Risk Management Professionals
- Compliance Officers
- Sponsors and CRO Representatives
- Clinical Operations Professionals
- Pharmacovigilance Specialists
- GCP Auditors
