Regulatory Open Forum

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  • 1.  PIP

    Posted 09-Sep-2011 09:32
    Does anyone have suggestions for a pediatric investigation plan?  I will be submitting one in the next few months.

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    Darlene O'Banion
    San Jose CA
    USA
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  • 2.  RE:PIP

    Posted 10-Sep-2011 22:55
    Hello,
    Here is an informative site on the EMA's website relating to PIPs:

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000293.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580025b91&jsenabled=true

    Hope this helps.

    Thanks,
    Brian

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    Brian Caselli
    Global Submission Manager
    Pfizer
    Groton CT
    United States
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    Original Message