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ICH Guideline Q9(R1) On QRM Part 1 Formality Risk-based Decisions

Published: February 28, 2023

The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While...

Source: pharmaceuticalonline.com

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United StatesKevin OdonnellStacey LargentDrexel UniversityLehigh UniversityGonzaga UniversityValsource IncVirginia Andreotti JonesQuality Risk ManagementCharacteristics RepresentativeVarying DegreesEquality RiskKevino DonnellRisk Based Decision MakingRisk ManagementPacific Northwest Chapter