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Open Scientific Discussion on "The Evolution of the M10 Guidance, the ICH Process, Adoption, & Implementation"

  • 1.  Open Scientific Discussion on "The Evolution of the M10 Guidance, the ICH Process, Adoption, & Implementation"

    Posted 06-21-2022 12:02

    Please join the AAPS Bioanalytical Community on June 29th @ 12pm EDT for an Open Scientific Discussion:
    The Evolution of the M10 Guidance, the ICH Process, Adoption, & Implementation

    The ICH Harmonised Guideline for Bioanalytical Method Validation and Study Sample Analysis (M10), endorsed by the members of the ICH assembly on 24 May 2022, is now published on the ICH website (https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf) Finalization of this globally harmonised bioanalytical guideline is a significant achievement and advancement.  Join us as experts in the field of Bioanalysis share the history of how this guideline came about, the process by which the working group progressed to a harmonised position, and what to expect now that ICH has published the guideline.  Please join us for this first OSD in a planned series for the community to interface and discuss ICH M10.

     

    Moderator: Stephanie Cape, LabCorp Drug Development

    Presenters: Enaksha Wickremsinhe (Eli Lilly & Company) & Faye Vazvaei-Smith (Merck & Co. Inc.)

    For more information, including calendar invites, and virtual meeting login info,
    please visit the EVENT PAGE Admission is free, so invite your friends!

    Interested in joining the Open Scientific Discussion committee or have an idea for an upcoming session? Please contact the OSD Committee Chair @ Sanjeev Bhardwaj

    Please join my meeting from your computer, tablet or smartphone.


    https://meet.goto.com/670052085

    You can also dial in using your phone.
    United States: +1 (669) 224-3412

    Access Code: 670-052-085

    Join from a video-conferencing room or system.
    Dial in or type: 67.217.95.2 or inroomlink.goto.com
    Meeting ID: 670 052 085
    Or dial directly: [email protected] or 67.217.95.2##670052085

    Get the app now and be ready when your first meeting starts: https://meet.goto.com/install  

    #bioanalysis #Bioanalytical #OSD #OpenScientificDiscussions



    ------------------------------
    Sanjeev Bhardwaj
    Sr. Scientist
    Janssen R&D
    Springhouse PA
    [email protected]

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