ICH E6 (R3) - GCP for Clinical Trials – What is new?

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: 8th & 9th May 2025

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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 that will be enforced in Europe on 23 July 2025. 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

We, at Wehive, offer you in-house training programmes conducted by inspiring coaches that are
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The new Principles of GCP
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New Principles in ICH-GCP R3
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Annex 1 - Impact of changes
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Assessment of the Appendices
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Comparison with ICH E6 (R2)
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Best practices for implementation of the new guideline

Learning Outcomes

  • Taking away the revised principles of Good Clinical Practice
  • Having full awareness of the impact of the third revision of ICH E6
  • 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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