Course overview
Risk management is now central to regulatory expectations in clinical research. Under ICH GCP E6 (R3) and ICH E8 (R1), sponsors and investigators must implement proportionate, risk-based approaches that protect participant safety, ensure data integrity, and demonstrate effective oversight throughout the clinical trial lifecycle.
Regulators increasingly expect organisations to show how risk is identified, assessed, managed and monitored in practice - not simply documented in theory.
This course provides a practical, inspection-focused guide to implementing risk management within clinical trials and clinical quality systems. It bridges regulatory expectations with real-world tools and processes that can be applied immediately in sponsor, CRO and study site environments.
CPD Hours: 6
Course Content
- Day 1
- Introduction to risk management in clinical trials
- Regulatory framework and critical-to-quality thinking
- Risk-based quality management systems
- Risk tools used in clinical trials
- Managing and monitoring risk in practice
- Risk-based oversight and continuous improvement
Speakers
Laura Brown
Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials including risk identification and management. She has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and is an international expert on GCP and clinical trial requirements. Laura was chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements.
