Advanced Good Clinical Practice ICH E6 (R3) Masterclass

The ICH GCP E6 (R3) guideline represents a transformative global shift in Good Clinical Practice (GCP), aligning with the evolving expectations of regulatory agencies. The update challenges sponsors, CROs, and sites to redefine their approach to compliance, quality, and clinical trial execution.

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Date: 22, 23, 24 July 2025

0 days 00 hr 00 min 00 sc
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Course Overview

The ICH GCP E6 (R3) guideline represents a transformative global shift in Good Clinical Practice (GCP), aligning with the evolving expectations of regulatory agencies. The update challenges sponsors, CROs, and sites to redefine their approach to compliance, quality, and clinical trial execution. This course provides an in-depth update covering the revised GCP requirements. Attendees will gain perspectives on the impact of relevant changes and actionable strategies how best to implement them. The course is packed with new information and will provide opportunities to discuss best working practices. The course is best suited for participants with previous ICH E6 experience and knowledge.

Key Topics

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ICH E6(R3): Understanding the key revisions and implications

The new Principles of GCP

Annex 1 and Annex 2 - Impact of changes and how best to ensure implementation

Updated Responsibilities: Risk and Data Changes

Assessment of the Appendices (Essential Records, Protocols, Investigator Brochures)

Comparison with ICH E6 (R2) and Becoming aware of the challenges and how to manage forthcoming inspections

Learning Outcomes

  • Are you recovering from a recent surgery?
  • Have you been injured at work or in an auto accident?
  • Developing full understanding how to implement the changes

Who Should Attend

  • Clinical Operations
  • Clinical Project Management
  • Clinical Quality Assurance
  • Clinical Quality Project Management
  • GCP Compliance
  • Clinical Process Management

Meet Your Trainer

Jeannette Dixon

Jeannette has held GCP quality-focused positions since 2008 at various pharmaceutical companies, and started her own consultancy business in 2017, including employment as Director R&D QA at A Gene Therapy biotech company. Prior to transitioning to GCP/GCLP work, she held positions in pharmaceutical training management, project management in Phase I-IV projects, worked as CRA and in academic research laboratories. Jeannette led quality teams and has extensive experience in Quality Management System (QMS) development, managing audits, CAPAs, risk management and inspection readiness activities as well as in hosting several regulatory agency inspections.

Her educational background is a BSc in Medical Sciences, a BSc in Pharmacology, and a Master in Quality Management. She enjoys traveling, cycling, swimming, and painting, and hopes to be able to see a few more deserts in the world

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