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GCP (Good Clinical Practice) and Clinical Research Update: What Inspectors Are Focusing on Now 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"

19 May 2026
+ 20 November 2026 »
from £649

Need help? Enrol/reserve

Course overview

Clinical research regulation continues to evolve, and keeping up with changes in GCP is an ongoing challenge for anyone working on clinical trials. Inspectors expect trial teams to understand not only what has changed in guidance and regulation, but how those requirements are being interpreted and applied in practice.

This one-day course provides a focused and practical update on the areas of GCP and clinical research regulation that are currently attracting the most attention during EU and FDA inspections. Rather than attempting to review regulatory guidance on a document-by-document basis, the course concentrates on how key principles from ICH GCP E6(R3), the EU Clinical Trials Regulation, and selected EU and FDA guidance are being tested during inspections.

The programme brings together:

Recent inspection trends and common findings
Practical interpretation of ICH GCP E6(R3) and related guidance
EU Clinical Trials Regulation requirements and CTIS expectations
FDA and EU regulatory thinking as reflected in inspection focus areas, questions, and observations

Throughout the day, EU and FDA guidance is addressed through inspection outcomes, regulatory expectations, and real-world examples, helping participants understand what inspectors are looking for now and how to demonstrate compliance in practice.
The emphasis is on interpretation, prioritisation, and practical impact on trial conduct, rather than theoretical review of guidance documents. The course is designed to help delegates refresh their knowledge, feel confident discussing current regulatory expectations during audits and inspections, and apply up-to-date GCP principles to how trials are actually run.

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

By attending this course, participants will:

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 being assessed by inspectors
Explore how inspectors are viewing 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 recent and up-to-date GCP training during inspections.

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

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

Enrol/reserve

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

19 May 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 16181

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

Until 14 Apr

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

View basket

Not ready to book yet?

for 7 days, no obligation

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

View basket

Not ready to book yet?

for 7 days, no obligation

* 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 GCP and Clinical Research Update: What Inspectors Are Focusing on Now 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