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  • 1.  ESG Test Webtrader Account

    Posted 03-Aug-2017 17:10
    Hi Folk,

    I have a quick question pertaining to ESG webtrader Test Account, In the final step what does it mean for "Guidance compliant test submission" is it just like a sample submission with fictional ANDA/NDA number and documents or the actual submission.
    your attention to this query will be higly appreciated.

    Thank you.

    ------------------------------
    Shahid Hussain
    MCPHS University
    Allston MA
    United States
    ------------------------------


  • 2.  RE: ESG Test Webtrader Account

    Posted 04-Aug-2017 03:34
    Hi Shahid,

    To which step are you currently from the FDA ESG Account Checklist? 

    The "Guidance compliant test submission" is basically a simulated event that you report with fictional details - it is not an actual submission. This test is for FDA to be sure you have understood the guidance and processes and are ready for actual reporting.

    I have experience with implementing an <g class="gr_ gr_594 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="594" data-gr-id="594">eMDR</g> system so if you have further questions, please feel free to contact me.

    ------------------------------
    Best Regards,

    Ioana Ulea
    Regulatory Affairs Professional
    Brussels, Belgium
    ------------------------------

    Original Message


  • 3.  RE: ESG Test Webtrader Account

    Posted 04-Aug-2017 11:07
    Thank you Guys for your attention and clarification.

    Currently I am at final stage (with webtrader test account) and need to send guidance compliant submission to migrated into production account.

    ------------------------------
    Shahid Hussain
    MCPHS University
    Allston MA
    United States
    ------------------------------

    Original Message


  • 4.  RE: ESG Test Webtrader Account

    Posted 04-Aug-2017 10:22

    I simply sent a sales brochure to both the FDA and a second submission for Health Canada.  I got receipt and acknowledgements for both.

     

    Thanks

     

    Al Van Houdt, RAC

    Sr. Mgr. Regulatory Affairs & Compliance

     

    Spacelabs Healthcare

    o 425-363-5970

    m 425-281-7683

    Fax 425-363-5762

    www.spacelabshealthcare.com

     




    Original Message


  • 5.  RE: ESG Test Webtrader Account

    Posted 04-Aug-2017 11:09
    Thank you very much.

    ------------------------------
    Shahid Hussain
    MCPHS University
    Allston MA
    United States
    ------------------------------

    Original Message


  • 6.  RE: ESG Test Webtrader Account

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2018 15:57
    This message was posted by a user wishing to remain anonymous

    ​Hi Shahid,

    Did you end up migrating your test account to the production account? What did you submit as part of the 'guidance compliant test submission'?

    Thank you
    Original Message


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