Introduction to Regulatory Affairs
BIOL-40402
This introductory course provides a comprehensive overview of the drug development process, from initial development through regulatory approval and commercialization. The course emphasizes the role of regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonization (ICH). Students will explore key aspects of regulatory compliance, including the roles and responsibilities of professionals across the pharmaceutical and biotechnology sectors, as well as the legal frameworks that govern the industry, such as the U.S. Food, Drug, and Cosmetic Act, the Code of Federal Regulations (CFR), and applicable international regulations.
What you'll learn
-
Describe the historical development of regulations governing drugs, biologics, and medical devices.
-
Explain the structure of the U.S. Food and Drug Administration (FDA) and its role in drug development.
-
Summarize the drug development lifecycle and the role of regulatory affairs professionals within it.
-
Identify appropriate regulatory pathways for drugs, biologics, and medical devices from discovery through marketing approval.
-
Recognize post-approval regulatory activities required for continued compliance and lifecycle management.
-
Discuss emerging trends in regulatory affairs, including artificial intelligence and global regulatory harmonization (e.g., ICH).
-
Apply foundational regulatory knowledge and professional principles to support success in a regulatory affairs career.
Course Information
Course sessions
Section ID:
Class type:
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
Policies:
- No refunds after: 4/13/2026