Regulatory Open Forum

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  • 1.  Pharmacovigilance

    Posted 20-Nov-2019 09:46
    Hello Everyone,
    Does the doctor who determines post-marketing SAEs (relatedness, etc.) have to be accredited by the USA? Or any doctor from outside of the USA can do that?

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    Artur Shchukin RAC, MS, ASQ-CQA
    Manager, RA/QA
    New York NY
    United States
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  • 2.  RE: Pharmacovigilance

    Posted 21-Nov-2019 08:24
    The US FDA does not require accreditation for manufacturer decision makers regard SAEs. I don't know of (m)any instances where "qualified by training and experience" will not satisfy FDA expectations on validity of such decisions.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


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