Course Description

The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This web seminar explores the changes in detail to promote a better understanding of how they impact clinical trials. Practical information and a systematic approach in assessing organizational SOPs, processes and practices as well as designing modifications to assist with implementation will also be provided.

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Learning Objectives

• Identify the changes impacting investigator responsibilities and roles
• Explain the impact of the revisions to sites and Sponsors-Investigators
• Evaluate solutions for applicability/modification of organizational SOPs, processes, procedures and staff training
• Apply lessons learned for effective implementation of the new ICH GCP E6 R2 guideline

Who Should Attend

• Quality Assurance/Compliance Personnel
• Principal Investigators/Sub-Investigators
• Research Site Staff (Managers, CRCs, Data Managers/Data Entry)
• Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
• Study Managers/Project Managers, CRAs/Monitors (Centralized, On-site)

Instructor

Mary Mills, R.N., C.C.R.A.

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