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 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.
Who Should Attend
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.
