Course Description

The release of ICH GCP E6(R3) represents a significant evolution in clinical trial management, building on the changes introduced in the R2 revision. With a focus on improving efficiency and adaptability in the face of growing trial complexity, the R3 updates bring more flexible and risk-based approaches to trial design, conduct, and oversight. This web seminar will guide participants through the essential updates in the ICH E6 guidelines, highlighting the direct impact on sponsors, CROs, and clinical trial teams. Practical strategies for incorporating these revisions into trial management processes will be explored, along with insights into how the R3 updates can streamline operational workflows while maintaining high standards of quality and compliance. Specific topics include the evolving roles of sponsors and CROs in this updated framework.

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Learning Objectives

• Identify three key changes in the ICH GCP E6(R3) updates that affect sponsors and CROs, along with their impact on individual roles
• Explain how the revisions influence clinical trial conduct and organizational practices
• Discuss practical opportunities for implementing the revised guideline to improve trial management efficiency and compliance

Who Should Attend

• Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
• Study Managers/Project Managers, Clinical Research Associates/ Monitors (Centralized, On-site)

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.