Quality Risk Management – ICH Q9 (R1)

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  • #4374
    Pharma Digests
    Pharma Expert

      What are the major changes in recently updated ICH Q9 (R1) guideline?

      #4765
      aid
      Participant

        The revised Guideline addresses what constitutes formality in QRM and it outlines how varying degrees of formality may be applied during QRM activities, including when making risk-based decisions.

        #5466
        Belal
        Participant

          To clarify the QRM formalities and risk-based decision making.

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