Undefined QTLs

Q: Are we at risk when a QTL is not defined?

A: The strategy here should be:

• Regular review of risk re-assessments (e.g., every quarter)
• Use mitigation actions as much as possible, even for unknown risks (according to ICH “risk reduction activities”)
• Apply PP and CSM for identification of residual or unknown risks
• Conclude & Implement further KRIs/QTLs based on CSM and PP findings
• Apply further KRIs/QTLs if identified that they are missing