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  • 1.  Annual Breakfast with Atlanta FDA District Officers

    Posted 26-Oct-2018 12:45

    Hello everyone,

    I joined RAPS back in July of this year and I'm thinking of attending the annual breakfast on 12/6/18. This will be my first time and was wondering if anyone could provide insight as to what the expectations are? How many people typically attend? I work for a small company and we own two ANADAs and two ANDAs. We currently outsource our submissions but are wanting to take steps to do this ourselves. I have a few questions concerning this. Would these questions be welcomed?


    Thank you

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    Allen Black
    North Augusta SC
    United States
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  • 2.  RE: Annual Breakfast with Atlanta FDA District Officers

    Posted 27-Oct-2018 08:44
    Hi Allen,
    I attended the breakfast last year and it was very informative.  I also use to work for FDA and the folks from FDA who are going to be there will be able to answer your questions.  Unfortunately, i wont be there because i have relocated to NYC.

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    Sheri Oliver-Lee
    Regulatory Affairs Manager
    New York
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    Original Message


  • 3.  RE: Annual Breakfast with Atlanta FDA District Officers

    Posted 27-Oct-2018 14:05
    I certainly hope you do decide to attend this year's FDA Breakfast event.  This event has historically been attended by approximately 100 area participants.  The attendees range from RA Specialists to the corporate CEOs.  It is an opportunity to ask questions during the presentation portion and during the networking portion of the event.  So yes, there is an opportunity to ask FDA direct questions and they can respond to the extent permitted by the agency.

    One of our speakers (LaReese Thomas, supervisor, Consumer Safety Office, Atlanta FDA District Office) will be discussing the FDA organizational changes from the pharmaceutical perspective.

    Feel free to contact me directly if you would like to discuss further.


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    Sylvie Verdon; MS, RAC, MPM
    Senior Consultant; REGSolutions, LLC
    Principal Consultant; Verdon Solutions, LLC
    RAPS Atlanta Chapter Co-Chair
    Alpharetta, GA USA
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    Original Message