An elective course in the Regulatory Affairs and Compliance Certificate Program.
With the expansion of global markets in the pharmaceutical industry, regulatory affairs professionals must be well-versed in multinational regulatory requirements. This course presents an overview of the regulatory agencies and regulations for drugs and biologics, in the European Union, Canada, Japan, and other major markets in comparison with the U.S. regulatory system. The course will explore topics that include international harmonization efforts, premarket regulations, authorization requirements, and regulatory agency enforcement. Students will learn how to apply knowledge of international regulations to formulate a global regulatory strategy for product development.
Prerequisites: Students should have a detailed understanding of US medical product regulation prior to taking this course.