Presented by
Management Forum
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 In-house Training
This one-day course focuses on what inspectors look for in clinical trials, covering ICH GCP E6(R3), the EU Clinical Trials Regulation, common findings, and practical steps to ensure compliance and inspection readiness.
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
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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
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 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
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
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).
Reviews of IPI's Preparing for GCP Inspections: Key Expectations under ICH GCP E6(R3), EU CTR and Current Regulatory Thinking training course
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Jan 29 2026
Denise Johnson 
Clinical Research Manager, SOMNOmedics AG
Jan 29 2026
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Denise Johnson
Clinical Research Manager, SOMNOmedics AG
Germany
- SOMNOmedics AG
United Kingdom
- Guy's Hospital
Run Preparing for GCP Inspections: Key Expectations under ICH GCP E6(R3), EU CTR and Current Regulatory Thinking Live online for your team
Pricing from:
- GBP 500
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
