Bioanalytical Community

 View Only

Updates to the BIOANALYTICAL COMMUNITY OSD ON ICH M10 IMPLEMENTATION FOR BIOANALYTICAL METHOD VALIDATION

  • 1.  Updates to the BIOANALYTICAL COMMUNITY OSD ON ICH M10 IMPLEMENTATION FOR BIOANALYTICAL METHOD VALIDATION

    Posted 04-21-2023 01:10

    Updates - A panel Member from the FDA added, Affiliation of one of the panel members updated

    Please join the AAPS Bioanalytical Community on May 22nd @ 12 pm EDT for an Open Scientific Discussion:

    ICH M10:  Panel Discussion on Implementation

    ICH M10 is now effective and has been adopted by several 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: Chad Briscoe (BA Community Co-Chair)

    Panel:   

    Chongwoo Yu (FDA)

    Jim Shen (BMS)

    Faye Vazvaei-Smith (Merck)

    Stephanie Cape (LabCorp)

    Tim Sangster (Celerion)

    Enaksha Wickremsinghe (Bill and Melinda Gates MRI)

    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 &/or Laurelle Calliste

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

    (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

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