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OSD: The Impact of the Latest FDA Regulations on Laboratory Developed Tests (LDTs)

  • 1.  OSD: The Impact of the Latest FDA Regulations on Laboratory Developed Tests (LDTs)

    Community Leadership
    Posted 05-31-2024 10:21

    Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Gene and Cell Therapy Products (GCTPs) and Biomarkers and Precision Medicine (BPM) Communities on the following topic:

    The Impact of the Latest FDA Regulations on Laboratory Developed Tests (LDTs)

    What are LDTs and their roles in clinical trials?

    What are the recent changes in FDA regulations?

    How would this impact us?

    Discussion Leaders:

    Kelly Gordon (Boudicca Dx)

    Mark Ma (Rallybio)

    Mark E. Arnold (Bioanalytical Solutions Integration)

    Organized by:  

    Yan G Ni (Passage Bio)

    Yanmei Lu (Sangamore)

    Carmen Fernandez-Metzler (PharmaCadence Analytical Services)

     

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

    (Please remain on mute unless asking questions)

    When: Monday June 10, 2024, 12 noon  – 1 pm EST

    WherePlease join from your computer, tablet or smartphone.

    https://meet.goto.com/505947717

    You can also dial in using your phone.
    United States: 
    +1 (646) 749-3122
    Access Code: 505-947-717

    Join from a video-conferencing room or system.
    Dial in or type: 
    67.217.95.2 or inroomlink.goto.com
    Meeting ID: 505-947-717
    Or dial directly
    [email protected] or 67.217.95.2##505947717

    New to GoToMeeting? Get the app now and be ready when your first meeting starts:
    https://global.gotomeeting.com/install/305789893

     

    Please feel free to share with colleagues who may be interested in this topic. Thank you!

    The AAPS GCTPs and BPM Community Leadership Teams



    ------------------------------
    Yan Ni Ph.D.
    Executive Director
    Passage Bio
    Philadelphia 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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