Course overview
Clinical trial regulations continue to evolve rapidly, particularly in Europe following the implementation of the EU Clinical Trials Regulation (536/2014) and the introduction of the Clinical Trials Information System (CTIS). These changes affect a wide range of roles involved in the planning, conduct, oversight, and support of clinical trials.
This course provides a structured, high-level overview of the regulatory framework governing clinical trials in Europe, with reference to key US requirements. It focuses on understanding regulatory expectations, roles, and responsibilities rather than hands-on system or submission training.
The programme is designed for professionals who need context, clarity, and confidence when working with regulatory colleagues, CROs, and inspectors.
CPD Hours: 12
Course Content
- Day 1
- Clinical trial regulatory framework in Europe
- EU Clinical Trials Regulation (536/2014)
- Clinical trial transparency
- Clinical trial authorisation - overview
- Day 2
- Introduction to CTIS
- Ethics committees and informed consent
- Paediatric clinical trials - overview
- Investigational medicinal products (IMP)
- Pharmacovigilance and safety reporting
- US clinical trial regulatory overview
- Regulatory inspections
- Recent and emerging developments
Speakers
Laura Brown
Dr Laura Brown is an independent QA and training consultant and director of the MSc in Clinical Research at Cardiff University’s School of Pharmacy. Laura has many years’ experience in the pharmaceutical industry, working for companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and as head of a training department and is an international expert on regulatory requirements in clinical research. She was Chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements. She has written several articles on the requirements of the EU Clinical Trial Regulation, the impact of Brexit on clinical trials and the ICH GCP R2 guideline.
