Regulatory Open Forum

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  • 1.  Postmarket Regulatory Responsibilities?

    Posted 25-Mar-2014 23:20
    Random Question of the Week:

    What do you think are the most critical post-market responsibilities for a Regulatory Affairs Department?


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    Julie Omohundro RAC (US, EU)
    Durham NC
    United States
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  • 2.  RE:Postmarket Regulatory Responsibilities?

    Posted 26-Mar-2014 00:37
    I would say Annual Product Surveillance Survey on safety and efficacy of the products marketed and monitoring on Medical Device Reporting database. 

    Thanks!
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    Winson Teng
    Regulatory Affairs Engineer
    Singapore
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    Original Message


  • 3.  RE:Postmarket Regulatory Responsibilities?

    Posted 27-Mar-2014 07:45
    On the CMC side, change control (and the required reporting that goes with it).

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    Rachel Thornton
    Associate Director
    UCB
    Smyrna GA
    United States
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    Original Message


  • 4.  RE:Postmarket Regulatory Responsibilities?

    Posted 27-Mar-2014 11:25
    I would say post marketing maintenance and promotional and advertising materials. 

    D

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    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 5.  RE:Postmarket Regulatory Responsibilities?

    Posted 28-Mar-2014 16:02

    I would say labeling defence.

    Thanks,
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    Yuko Komokata
    Daiichi Sankyo Co., Ltd.
    Edison NJ
    United States
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    Original Message