GCP Risk Management and Risk-Based Monitoring

New regulations with regard to Risk Based Monitoring were released by the FDA to build on those for Quality Risk Management - ICH Q9 (R1). The regulatory drive towards adopting a risk based approach was strengthened with the release of the ICH GCP E6 (R3) guideline 2022.

In addition there is permanent pressure on resources for clinical trials and it is vital that those precious resources are utilized where they deliver greatest benefit.

This course provides an understanding of risk management principles and makes the links between study level risk management and the implementation of risk based monitoring.

Areas Covered in the Session :

• Regulatory requirement
• Broad review of risk based activities
• Study level risk management
• RBM – adding value to your operations
• What may generate risk?
• Risk management documentation/risk statement structure
• How to get started
• Actions and how to manage them
• Practical implications

Who Should Attend:

• Clinical Research Associates
• Monitors
• Data Management Teams
• Project Management Statisticians
• Clinical Research Outsourcing
• Drug Suppliers
• All clinical research professional embarking on a risk-based approach

Course Director: CHARLES H. PAUL 

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.