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FDA and Industry Panel discussion - Challenges and Opportunities with ICH Q14 Implementation

  • 1.  FDA and Industry Panel discussion - Challenges and Opportunities with ICH Q14 Implementation

    Community Leadership
    Posted 08-26-2024 21:29
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    Please join us on Sept 27 for an engaging virtual panel discussion on "Challenges and Opportunities in the ICH Q14 Implementation."  This session seeks to share:

    •         Industry and FDA's experiences with ICH Q14 as well as potential challenges and opportunities

    •         Expectations to establish acceptance criteria and confidence limit

    •         The tools used to facilitate analytical changes based on ICH Q14.

    •         Opportunities to provide submissions with enhanced conditions (ECs).

    •         Opportunities for post-approval changes with EC developments

    (see attachment for details)



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    Andrea Schirmer
    Sr. Research Fellow - CMC Expert
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Ridgefield CT
    [email protected]

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