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International Regulatory Affairs Apotex

APT816

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APT816 - International Regulatory Affairs Apotex

Prerequisites:

PFT/APT815 - Advanced Regulatory Affairs

This course provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in USA, European countries, Japan and MENA region are examined as well as the regulations in a selected number of other geographic locations. Drug submission requirements based regulations in these countries are compared.


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