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.
Count Every Second Until the Event
Date: 9-11 September 2026
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 practical insight into the impact of the revised requirements and actionable strategies for effective implementation.
The course is packed with 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
ICH E6(R3): key revisions, timelines and implementation expectations
New and revised GCP principles
Annex 1 and Annex 2: impact of changes and implementation considerations
Revised Investigator, Ethics Committee and Sponsor responsibilities
Quality Risk Management, Quality by Design and Critical to Quality Factors
Data Governance and computerised systems expectations
Essential Records, Protocols and Investigator Brochures
TMF inspection observations and documentation expectations
Learning Outcomes
Who Should Attend
- Clinical Operations professionals
- Clinical Project Managers
- Clinical Quality Assurance professionals
- GCP Compliance professionals
- Clinical Quality / Compliance Managers
- Sponsor Oversight professionals
- Clinical Process Management professionals
- Clinical Trial Managers / Study Managers
- Regulatory and inspection-readiness professionals
- Professionals with previous ICH E6 / GCP experience
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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