Learn more about the academic programs we are delivering in Summer 2025. If you have any questions about part-time studies, please contact us.
Prerequisites:
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.