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.
CPD Hours: 6
Course Content
- Day 1
- Introduction and objectives
- Stakeholder responsibilities
- Risk-based approaches
- Data governance and integrity
- Data and records
- Investigator brochures
- Protocols
- Essential records
- Preparing for Regulatory Inspections
- Implementation considerations
Speakers
Laura Brown
Dr Laura Brown is an independent quality assurance and training consultant with extensive experience in clinical research and GCP compliance. She was formerly Course Director of the MSc in Clinical Research at the School of Pharmacy, Cardiff University, and Course Director of the MSc in Regulatory Affairs at the University of Hertfordshire.
Laura has managed and supported GCP inspections across the pharmaceutical industry and has held roles including Clinical Research Manager, Audit Director and Head of Training. She chaired the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements, including ICH GCP E6 (R2) and (R3).
Who Should Attend
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
