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EMA releases guideline on implementing ICH M10 based on the stage of clinical development

  • 1.  EMA releases guideline on implementing ICH M10 based on the stage of clinical development

    Posted 11-22-2023 13:40

    EMA has taken an ICH M10 implementation approach based on a program's stage of development vs  the EMA implementation date of 21January2023 when all validations should comply.  3 other scenarios are outlined:

    1) If your development program started shortly before 21Jan23- consider transitioning to ICH M10

    2) Program is in phase 3 - ongoing studies may complete against the EMA BMV from 2011. 

    3) The nonclinical (GLP) program is complete and assays were run and samples were analyzed preior to 21Jan23, no need to transition or repeat work if the work was performed in compliance with the 2011 EMA BMV

    #EMA #ICH_M10_Implementation

    Link to guideline



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    Mark Arnold Ph.D., FAAPS
    Westampton, NJ
    [email protected]
    Bioanalytical Solution Integration
    LinkedIn: https://www.linkedin.com/in/markearnoldphd/
    Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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    </bioanalysisandbiomarkers.blogspot.com>