Introduction to Regulatory Affairs in the US and Canada
This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada. It highlights the agencies primarily responsible for regulating healthcare products—the US Food and Drug Administration (FDA) and Health Canada. The course highlights the applicable legislation that drives the regulatory processes.
At a Glance
- Target Audience: This course is geared toward entry-level regulatory professionals, professionals from other areas serving on a regulatory team and individuals seeking to gain a better understanding of the North American regulatory framework.
- Learning Level: Basic
- Total Length of Course: 2 Hours
- RAC Points: 2
- Medical Device Certificate Elective
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Identify the organizations involved in the US and Canadian regulatory system, how they are organized and the products they regulate
- Recognize the regulatory instruments—acts, regulations and/or guidances—and how they are applied
- Outline the basic regulatory processes used by FDA and Health Canada
- Identify peripheral agencies outside FDA and Health Canada involved in governing healthcare products
Lesson Titles
- Lesson 1: Overview of US Regulatory Systems and Agencies
- Lesson 2: Overview of Canadian Regulatory Systems and Agencies
This course is also included in:
