Overview of Global Regulatory Affairs
An elective course in the Regulatory Affairs & Compliance for Medical Devices and Regulatory Affairs & Compliance for Pharmaceuticals Certificate Programs.
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.
