Regulatory Open Forum

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  • 1.  eCTD Workshop

    Posted 13-Jun-2017 07:10
    Hello,

    I am looking for a eCTD workshop or seminar. RAPS just had one in April, and I am wondering if they are annual or if there is usually one in the Fall. The sooner the better. If not, are there other organizations that have a good eCTD workshop or seminar? The more intense or in-depth the better. IOW, I am looking for something more than just an easy online course that may not really add much to my knowledge base.

    Thanks,

    Wes


  • 2.  RE: eCTD Workshop

    Posted 13-Jun-2017 09:57

    Actually, we have two happening in fall:
    1) October 17-18 in San Diego (registration is already open)
    2) October 30-31 in Frankfurt, Germany (registration will open within a week)

    Bill



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    Bill Bridges
    RAPS
    Rockville MD
    United States
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  • 3.  RE: eCTD Workshop

    Posted 14-Jun-2017 17:24
    You can try below options:

    1) Electronic Common Technical Document (eCTD): Overview and Submission
    Fda remove preview
    Electronic Common Technical Document (eCTD): Overview and Submission
    Welcome to the Electronic Common Technical Document (eCTD): Overview and Submission Web-Based Training (WBT) course. This course will walk you through the essential steps of submitting electronic submissions to the Center for Drug Evaluation and Research (CDER), and can serve as a resource for questions about the submission process.
    View this on Fda >


    2) eCTD Submissions Process for US FDA, EU & Canada | Workshop by Ex-FDA Official
    Complianceonline remove preview
    eCTD Submissions Process for US FDA, EU & Canada | Workshop by Ex-FDA Official
    Peggy J. Berry MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official) Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.
    View this on Complianceonline >


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    Gaurang Bhavsar
    Edison NJ
    United States
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