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