Dublin, April 14, 2026 (GLOBE NEWSWIRE) -- The "Preparing for GCP Inspections: Key Expectations under ICH GCP E6(R3), EU CTR and Current Regulatory Thinking (July 13, 2026)" training has been added to ResearchAndMarkets.com's offering.
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.
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.
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.
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
Key Topics Covered:
- Inspection trends and common findings
- ICH GCP E6(R3): what has changed
- Data integrity and trial oversight
- EU Clinical Trials Regulation (536/2014)
- Essential documents and the TMF
- Technology and future 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).
For more information about this training visit https://www.researchandmarkets.com/r/x6ekap
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