Regulatory Open Forum

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  • 1.  Do you use a software for tracking International Registrations?

    Posted 08-Feb-2017 07:42

    Hello!  Wanted to gather feedback.  Do you use a RIM software for managing International Registrations or have you investigated using one?  If so, I wanted to hear feedback – what programs would you recommend?

     

     

    Colleen Watson O'Keeffe, MS, RAC

    International Regulatory Affairs Manager

    Anesthesia & Respiratory Disposables

    Vital Signs & AirLife

     

    75 North Fairway Drive

    Vernon Hills, IL 60061, USA

    * Colleen.OKeeffe@CareFusion.com     

    ( 847 362 9579 

    Fax  312 949-6199

     

    image001.png@01D21EEB.D6B13050

    carefusion.com

     


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  • 2.  RE: Do you use a software for tracking International Registrations?

    Posted 09-Feb-2017 08:31
    Great question.  I am most interested.  Tracking international registrations is a challenge.  

    Along the same topic, do you have a defined process for managing registrations?

    ------------------------------
    Whitney Davis
    Global Regulatory Affairs Specialist
    Laboratory Products Division
    Thermofisher Scientific
    Marietta, OH
    USA
    ------------------------------

    Original Message


  • 3.  RE: Do you use a software for tracking International Registrations?

    Posted 10-Feb-2017 03:19
    I have been using very simple excel sheets, having cut the information of the technical dossier in bits and pieces in different columns to know exactly what was submitted where, plus  a few columns to allow entering more specific changes.
    The administrative information was kept in the country specific dossiers.

    Patrick

    Patrick Manouvriez
    MP.QRA Services sprl








    Original Message


  • 4.  RE: Do you use a software for tracking International Registrations?

    Posted 10-Feb-2017 06:24
    We researched using Trackwise at my previous  company. There is a Regulatory module. In the end we didn't buy anything, but that would have been our choice. 

    Yashieka Blount, MSHS
    Manager, Regulatory Affairs
    Biotest Pharmaceutical Corp. 

    --
    Shieka Blount
    m 201.218.2943 






    Original Message


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