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  • 1.  EMA Reflection Paper on AI in Drug Development

    Posted 18-Jul-2023 18:48

    The Regulatory Recon this week had an update about an EMA Reflection Paper on the use of AI/ML in drug development:
    "EMA to drug developers on AI: Carry out thorough risk assessments (Endpoints)"

    I cannot locate this discussion paper, and the link in the Endpoints article that purports to direct one to it is broken. Has anyone else been able to find this paper?

    Thank you!



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    Jess Ross
    San Francisco CA
    United States
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  • 2.  RE: EMA Reflection Paper on AI in Drug Development

    Posted 19-Jul-2023 06:03

    Jess, here's the direct link to the EMA Reflection Paper: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf



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    Jonathan Amaya-Hodges
    Director, Technical Services
    Sharon MA
    United States
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    Original Message


  • 3.  RE: EMA Reflection Paper on AI in Drug Development

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2023 09:12
    This message was posted by a user wishing to remain anonymous

    Looks like it's being taken back for some last minute changes.

    In the meantime, Google has a cached copy:

    https://webcache.googleusercontent.com/search?q=cache:6MXrW2KV970J:https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf&cd=9&hl=en&ct=clnk&gl=au&client=safari


    Original Message


  • 4.  RE: EMA Reflection Paper on AI in Drug Development

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2023 09:12
    This message was posted by a user wishing to remain anonymous

    Hi, thank you for this post. Here is the link to this discussion paper, but it seems the PDF does not exist currently:  https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf.


    Original Message


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