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.
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.
