ICH GCP (Good Clinical Practice) E6 (R3): What You Need to Know for Implementation and Inspection In-house Training

Course overview

This course focuses on the practical implications of the ICH GCP E6 (R3) guideline and what it means for the conduct and oversight of modern clinical trials. While the core principles of GCP remain unchanged, E6 (R3) introduces clearer expectations around risk-based approaches, oversight, roles and responsibilities, and the use of data and technology.

The course is designed to help clinical research professionals understand what has changed, how organisations are applying the new requirements in practice, and what regulators and inspectors are likely to focus on during GCP inspections.

Through practical examples, the session explores how sponsors, CROs and investigator sites are adapting governance, oversight, and decision-making under E6 (R3), with particular focus on inspection readiness.

By the end of the course, delegates will have a clear understanding of how to implement ICH GCP E6 (R3) in a practical and inspection-ready way.

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Benefits of attending

By attending this course, delegates will be able to:

• Understand the key updates and principles of ICH GCP E6 (R3)
• See how the E6 (R3) requirements are being implemented by companies, using practical examples
• Understand how GCP inspections are evolving under E6 (R3) and what inspectors are likely to focus on
• Apply risk-based approaches to clinical trial design, oversight, and monitoring
• Share experiences and insights with peers facing similar implementation challenges

Who should attend

This course is suitable for anyone involved in the planning, conduct, oversight, or support of clinical trials. It is applicable across Pharma, Biopharma, Clinical Research Organisations (CROs), service providers, and investigator sites. While focused on ICH GCP E6(R3), the principles discussed are relevant to any organisation involved in the conduct and oversight of regulated clinical investigations.

The course is particularly relevant for:

• Clinical Research Associates (CRAs)
• Clinical Trial Managers and Project Managers
• Regulatory Affairs Professionals
• Quality Assurance Personnel
• Investigators and Site Staff
• Data Managers
• Anyone involved in the design, execution, oversight, or governance of clinical trials