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Courses Offered : Regulatory Affairs, DMF & Dossier review, ICH Quality guidelines

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    Knowledge Domain

    unites-states

    Important links
    Website- http://www.fda.gov
    Newsroom- http://www.fda.gov/NewsEvents/Newsroom/default.htm
    Regulatory information by USFDA-http://www.fda.gov/Drugs/default.htm

    Important links
    News-https://www.edqm.eu/en/EDQM-news-525.html
    CEP information- https://www.edqm.eu/en/certificate-suitability-new-applications
    For all guidelines by EDQM- https://www.edqm.eu/en/Certification-Policy-documents-Guidelines-1658.html

    Europe
    RestOfthe world

    Important links
    Brazil- http://portal.anvisa.gov.br/
    http://portal.salud.gob.mx/
    Japan- http://www.mhlw.go.jp/english/
    India- www.cdsco.gov.in

    Important links
    Homepage- http://www.ich.org/
    M4 Common Technical Document-
    http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html

    ich
    gmp

    Important links
    Schedule M- https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/
    EudraLex- http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

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