Systematic Risk Assessment for Risk-Based Monitoring
Risk Management, RMPs, and REMS
Quality Risk Management
What is Quality Risk Management?Quality Risk Management (QRM) systematically uses risk as a marker for efficient deployment of resources to correct conditions that may otherwise compromise the quality of a process. As ICH-Q9 cites, the two primary principles of quality risk management are:
- The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and
- The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk
Click Here to visit ICH-Q9 document cited above.