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OSD on ICH M10: Panel Discussion on Implementation

  • 1.  OSD on ICH M10: Panel Discussion on Implementation

    Posted 08-24-2023 18:02

    Please join the AAPS Bioanalytical Community on September 13th@ 12 pm EDT for an Open Scientific Discussion:

    ICH M10: Panel Discussion on Implementation

    ICH M10 is now effective and has been adopted by many Country Health Authorities. This panel discussion will focus on practical questions and challenges on implementation with a focus on topics such as documentation, co-existence with still effective FDA BMV 2018 Guidance, and what has actually changed in laboratory validation and testing practices.

    Moderator: Robert Dodge (BA Community Co-Chair)

    Panel:      Johanna Mora (BMS)

                     Tong Yuan Yang (Janssen)

                     Michelle Miller (BioAgilytix)

                     Linlin Luo (Merck)

                     Marianne Fjording (Biolyzr)

         Chongwoo Yu (US-FDA)

         Murali Matta (US-FDA)

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

    Have an idea for an upcoming session?

    Please contact the OSD Committee Co-Chairs, Sanjeev Bhardwaj & Laurelle Calliste

    We start at 12:00 EST sharp. Please dial in before noon to avoid interruptions and mute yourself until the Q&A starts.

    You are encouraged to submit questions in the discussions section of the Bioanalytical Community Page prior to the event.

    (Please remain on mute and submit your questions via the Chat feature of GoToMeeting)

    Please join from your computer, Tablet, or smartphone.

    https://meet.goto.com/BA-OSD

    You can also dial in using your phone.
    Access Code: 871-534-861
    United States: +1 (571) 317-3122
    Join from a video-conferencing room or system.
    Meeting ID: 871-534-861
    Dial in or type: 67.217.95.2 or inroomlink.goto.com
    Or dial directly: [email protected] or 67.217.95.2##871534861
    Get the app now and be ready when your first meeting starts:
    https://meet.goto.com/install

    #bioanalysis #Bioanalytical #OSD #OpenScientificDiscussions



    ------------------------------
    Sanjeev Bhardwaj
    Moderna Therapeutics
    Cambridge, MA.
    [email protected]

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