Course Description

For the first time in over 20 years, the International Council for Harmonization (ICH) Good Clinical Practice (GCP) E6 R2 Guideline has been significantly updated. The revisions are intended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. But, the changes have resounding effects on the conduct of clinical research by sponsors/CROs and investigators.

This web seminar provides a targeted overview of the changes with summary explanations of the changes, per the Guideline. Topics include: ICH principles, ICH definitions, sponsor/CRO responsibilities, investigator responsibilities, and essential documents. Understanding these changes and how they impact your organization is the first critical step towards organizational analysis implementation.

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Learning Objectives

• Explain the rationale for the ICH GCP addendum (E6 R2)
• Describe the E6 R2 terms that are new/updated
• Identify the individual changes that comprise E6 R2
• Recognize the importance and impact of the E6 R2 changes for the sponsor/CRO and investigators/sites responsibilities

Who Should Attend

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

Instructor

Debbie Harper, B.Sc., P.M.P.

Click here for complete trainer biographies

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