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
Did this answer your question? Thanks for the feedback There was a problem submitting your feedback. Please try again later.