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.
CPD Hours: 6
Course Content
- Day 1
- 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).
