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

Get clear, actionable guidance on E6(R3) requirements for digital tools, AI, risk-based approaches, and quality-by-design. Learn how to apply them to trial conduct, oversight, and regulatory readiness using real-world examples.

13 July 2026 »
from £649

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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.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Understand the key updates and principles of ICH GCP E6 (R3)
Learn 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

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This course will cover:

Introduction and objectives

Introduction to ICH GCP E6 (R3)
Core Principles of ICH GCP E6 (R3)

Stakeholder responsibilities

Roles of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
Investigator obligations
Sponsor Responsibilities
Service providers

Risk-based approaches

Data governance and integrity

Data and records

Investigator brochures

Protocols

Essential records

Preparing for regulatory inspections

Implementation considerations

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Laura Brown
Independent Pharmaceutical Consultant

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).

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

13 July 2026

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 16055

GBP 649 749
EUR 909 1,049
USD 1,043 1,199

Until 08 Jun

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.