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Preparing for GCP (Good Clinical Practice) Inspections: Key Expectations under ICH GCP (Good Clinical Practice) E6(R3), EU (European Union) CTR and Current Regulatory Thinking Training Course

This course provides the latest updates on the finalised ICH GCP E6 R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.

★★★★★ "Very well done and would recommend to others"

20 November 2026 »
from £649

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Course overview

Regulatory expectations in clinical research continue to evolve, particularly with the introduction of ICH GCP E6(R3) and the implementation of the EU Clinical Trials Regulation (CTR). Regulators are increasingly focusing on risk‑based governance, data integrity, oversight of vendors and CROs, and the use of technology and digital processes in trials.

This practical one‑day course focuses on what inspectors from EU authorities, the MHRA and the FDA are currently looking for during inspections. Rather than reviewing guidance documents in isolation, the programme concentrates on how regulatory expectations are interpreted and applied in real inspection situations.

Participants will gain a clear understanding of the most common inspection findings, how organisations are challenged by regulators, and the practical steps that clinical teams can take to demonstrate compliance and inspection readiness.

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

Gain a clear overview of current inspection focus areas
Understand the most important changes introduced by ICH GCP E6(R3)
Clarify expectations around risk‑based approaches, governance and oversight
Refresh their understanding of essential documentation and TMF requirements
Understand how data integrity is assessed during inspections
Explore how inspectors view technology, digitalisation and AI in trials

Who should attend

This course is suitable for professionals who need to stay current with GCP requirements and inspection expectations, including:

Clinical Research and Clinical Operations professionals
Regulatory Affairs professionals supporting clinical trials
Quality Assurance and Audit professionals
Pharmacovigilance professionals involved in trial oversight
CRO and vendor staff working with sponsors
Academic trialists involved in regulated studies

It is particularly relevant for those who need to demonstrate up‑to‑date GCP training during inspections or audits.

Enrol/reserve

This course will cover:

Inspection trends and common findings

Overview of recent EMA, MHRA and FDA inspection themes
Areas where organisations are most frequently challenged
Examples of common inspection findings

ICH GCP E6(R3): what has changed

Key updates and revised expectations
Annex 1: what it means in practice
Risk‑proportionate approaches and governance
Links to ICH E8 and quality by design

Data integrity and trial oversight

What inspectors expect to see
Common weaknesses and how they arise
Practical steps to strengthen data integrity governance

EU Clinical Trials Regulation (536/2014)

Key requirements and practical implications
CTIS: common challenges and inspection considerations
Serious breaches and reporting expectations

Essential documents and the TMF

Common TMF-related findings
Structure, control, and oversight of the TMF
eTMF considerations, archiving, and retention

Technology and future considerations

Digitalisation and decentralised trials
Electronic informed consent
Real-world data in clinical research
Artificial intelligence: current regulatory thinking

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Laura Brown
Independent Pharmaceutical Consultant

Dr Laura Brown is an independent QA and training consultant and director of the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has many years’ experience of managing GCP inspections in the pharmaceutical industry and has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and head of a training department. She is an international expert on GCP and clinical trial requirements and was chair of the Institute of Clinical Research GCP Forum for six years. Laura writes regularly on clinical research regulatory requirements and has written a chapter in International Pharmaceutical Product Registration and several articles on the EU Clinical Trial Regulation, Brexit, and ICH GCP R2.

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

20 November 2026

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 16558

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

Until 16 Oct

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.

Reviews of IPI's Preparing for GCP Inspections: Key Expectations under ICH GCP E6(R3), EU CTR and Current Regulatory Thinking training course

The overview was great, information clear and shared with links.

Jul 1 2024

Ana Karla Uribe Rivera France
Research Fellow of Image Guided Surgery, IHU, Strasbourg

Nov 22 2024

Overall the webinar was well-presented, the content provided was very detailed and the speaker [k]new the topic well.

Davinia-Ann Cardona Malta
Quality Associate, Orphalan Ltd.

Mar 10 2023

Very well done and would recommend to others

Jaclyn Verrow United States of America
Director, TMF Compliance & Oversight, Vertex Pharmaceuticals

Mar 10 2022

Very good presentation and useful information with links, examples and clips which made it more interesting.

Kianoosh Khaksar Denmark
Compliance Specialist, Lundbeck

Sep 24 2021

[Laura] is a good presenter, she has world of knowledge. She was also able to get open discussion with the participant which made the course more interesting.

Angelo Jacala United States of America
Director, Clinical QA, MEI Pharma

Mar 29 2019

Very good and worthwhile attending.

Christopher Rollinson United Kingdom
Research Governance Manager, University Hospitals Plymouth NHS Trust

Sep 25 2018

It was understandable and fullfiled my expectations. I received many useful links and publications, which I can search for. The content was good but a bit too much information in a short timeslot.

Ines Kovacikova United Kingdom
Lead CRA, Octapharma Pharmazeutika Produktionsges.m.b.H.

United Kingdom