Course Description

The release of ICH GCP E6(R3) marks a significant update to the previous versions of the guidelines, reflecting a more flexible, risk-based approach to clinical trial management. This revision enhances the framework for clinical trial design, conduct, oversight, and reporting, with an emphasis on improving trial efficiency, data integrity, and the protection of human subjects. The R3 update also refines roles and responsibilities for sponsors, CROs, and clinical investigators/sites, aligning them with current best practices and regulatory expectations. This web seminar will provide an overview of the key updates in ICH GCP E6(R3), including new definitions, sponsor/CRO and investigator responsibilities, and essential documents. We will also explore how these updates influence clinical trial processes and provide practical guidance on how to implement these changes within your organization.

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Learning Objectives

• Explain the rationale behind the ICH GCP E6(R3) updates, and their intended impact on clinical trial management
• Describe the key terms and definitions that were introduced or updated in the ICH GCP E6(R3)
• Identify the specific changes in the ICH GCP E6(R3) update and proposed updates impacting sponsors, CROs, and clinical investigators/sites
• Recognize the significance of these changes for sponsor/CRO and investigator/site responsibilities, and their potential impact on clinical trial conduct

Who Should Attend

• Managers/Directors: Clinical Operations, Clinical Research, Quality Management, Compliance
• Study Managers, Project Managers
• Clinical Research Associates/Monitors
• Quality Assurance Personnel

Instructor

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB

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