Regulatory Open Forum

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  • 1.  eCTD Training Workshops

    Posted 12-Aug-2020 07:57
    Hi RAPS community,

    I was wondering if anyone has any recommendations for Electronic Common Technical Document (eCTD) Submission Training? I am preparing submissions for an IND, NDA/BLA and a CTA-As and need to get more comfortable with the process. I would really appreciate any advice, tips, and resources to get started.

    Thanks!


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    Luisa Garzon


    Burlington ON
    Canada
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  • 2.  RE: eCTD Training Workshops

    Posted 14-Aug-2020 19:07
    I'm in the same position. I believe the best thing is to get a training from the publishing software company you are using.

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    Artur Shchukin RAC, MS, ASQ-CQA
    Manager, RA/QA
    New York NY
    United States
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    Original Message


  • 3.  RE: eCTD Training Workshops

    Posted 15-Aug-2020 10:00
    RAPS gives this kind of training. See https://www.raps.org/events?pgindex=2 and scroll down to October.
    RAPS eCTD training


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    Michael Hellerstein
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    Original Message


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