IRA815 - International Regulatory Affairs and Harmonization

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Last revision date May 1, 2019 8:46:06 AM
Last review date May 1, 2019 8:46:06 AM

Subject Title
International Regulatory Affairs and Harmonization

Subject Description
This subject 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.

Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

Describe the regulatory process of pharmaceutical products in the USA, Europe, Japan and those in major locations.


Understand the basics of regulatory submission strategies and pathways in developed markets.


Appreciate the need for global harmonization and understand Mutual Recognition Agreements (MRA) between countries.


Describe the ICH (International Conference on Harmonization) and demonstrate a familiarity with the past and current issues being addressed by the ICH and understand the history of the ICH Meetings and Conferences.


Demonstrate a familiarity with specific ICH guidelines that have helped in global harmonization. 


Describe and compare the regulatory process and regulatory environment of pharmaceutical products in emerging and developing markets


Appreciate the importance of emerging markets in the growth of pharmaceutical marketing and regulatory affairs profession.


Demonstrate an understanding of requirements of global formulation and dossiers.


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