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?

    Artur Shchukin RAC, MS, ASQ-CQA
    Manager, RA/QA
    New York NY
    United States

  • 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.

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