International Regulatory Affairs and Harmonization

IRA815

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IRA815 - International Regulatory Affairs and Harmonization

Corequisites:

PRA700

This course provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in European countries, Japan and USA are examined as well as the regulations in a selected number of other geographic locations. Specification criteria and tests with drug substances and drug products are compared and the reasons behind regulations and controls are examined.


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