PHRMSCI X490

Overview of Global Regulatory Affairs

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.

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Course
Approximate Cost $735
Format Online
Duration 10 Weeks
Total Credits 3

WINTER 2024

1/8/2024 - 3/17/2024
Weeks 10
Delivery Online
Fee $735
Status Closed