Risk Management and Risk-Based Monitoring 2016

Topics

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

Who should Attend

Senior attendees involved or interested in:

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