Regulatory Open Forum

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  • 1.  Measuring Submissions

    Posted 17-May-2012 13:21

    Hello - thanks to those who have posted so many useful questions followed by good discussions.

    Question:  do you or your company "measure" submissions in any way?
    • Submission vs. approval times?
    • AI letters such as:
    - metrics, types of questions, branch, reviewer, root cause, responses, etc?

    Thanks,


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    Frank Pokrop
    Dir. Regulatory Affairs
    Carefusion
    San Diego CA
    United States
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  • 2.  RE:Measuring Submissions

    Posted 18-May-2012 08:43

    Hi Frank,

    Although I didn't get the opportunity to visit the tracking in an eCTD publishing system (ie. Insight, ISI, Octagon) most have a feature for regulatory tracking that I assume go into to details for "measuring submissions".  

    At my previous job I created a MS Access database to track regulatory submissions and product information.  We talked about getting into the level you are looking at but never got there.  


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    Alison Trado
    Regulatory Affairs Manager
    Hill Dermaceuticals, Inc.
    Sanford FL
    United States
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    Original Message


  • 3.  RE:Measuring Submissions

    Posted 19-May-2012 11:37
    It seems like the type of the measurements you want to track willdepend on your purpose in tracking them.

    For example, if you are looking for quality metrics to improve your inhouse process, I'm doubtful that tracking the branch and reviewer would do you much good, because you don't get to choose the branch or reviewer.  On the other hand, f you are looking for metrics to improve your planning, then it could be useful to know that you will need to plan for longer/shorter review times, more/less questions, etc, if you are submitting to one branch or another.  If you tend to work with the same reviewers repeatedly, then it might also be useful to know if a particular reviewer is inclined to focus on particular issues over others.

    Julie Omohundro RAC
    RAQA Infrastructure Services
    Research Triangle Park NC
    United States


    Original Message