Risk Management and Risk Based Monitoring

New regulations with regard to Risk Based Monitoring were released by the FDA in August 2013 to build on those for Quality Risk Management (ICH Q9). The regulatory drive towards adopting a risk based approach was strengthened with the release of the ICH GCP E6 (R2) guideline 2015.

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: SUE FITZPATRICK

Sue Fitzpatrick joined the Pharmaceutical Industry in 1980. She has been responsible for the management and audit of CRAs and clinical trials in a wide range of therapeutic areas. As former Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and postgraduate courses in collaboration with several UK Universities. Sue continues her collaborations and is an accredited teacher with Cranfield University. Sue is currently a Director of Redtree people working on employability skills to help new entrants enter the sector. She has authored many articles and books on clinical research and career development topics. Sue is currently working on a book in Clinical and Healthcare Research for publication with the Oxford University Press.