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  • 1.  ICHM10 FINALLY implemented in Japan

    Posted 12-06-2024 09:13

    Dear Bioanalytical Community,

    Just sharing the information that ICHM10 FINALLY migrated to Step 5 in Japan as of Dec-4, 2024.

    Note: PMDA allows the pharma/CRO to use the old Japanese guidelines for the determinations which stared / will start by Sep-30, 2025.

    If there are any questions, please contact JBF.

    Japan Bioanalysis Forum | バイオアナリシスフォーラム



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    Hisanori Hara
    Immunogenicity Advisor and
    EU/Asia Business
    B2S Life Sciences®
    [email protected] | www.B2SLifeSciences.com
    97 East Monroe Street, Franklin IN 46131, USA
    +1 317 721 5945 (direct)

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: ICHM10 FINALLY implemented in Japan

    Posted 12-09-2024 08:43

    Thank you for sharing this important information!



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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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    Original Message


  • 3.  RE: ICHM10 FINALLY implemented in Japan

    Posted 12-09-2024 15:05

    Dear Hisanori

    Thank you for this important update. ICH M10 is now implemented around the globe!

    BR

    Marianne



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    Marianne Scheel Fjording CEO
    Biolyzr Bioanalysis Excellence

    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message