Course

International Regulatory Affairs

BIOL-40407

This course provides an applied, career-focused overview of international regulatory affairs for drugs and biologics. Students will explore how regulatory principles are implemented across global markets, including the United States, European Union, and key international regions. Emphasis is placed on global regulatory strategy, leveraging international collaboration initiatives and agreements, submission planning and execution, and post-approval lifecycle management.

Learning Objectivs

Integrate U.S.-based regulatory knowledge into global development and approval strategies across multiple regions.
Analyze and compare regulatory frameworks and requirements among major health authorities, including the U.S. Food and Drug Administration and European Medicines Agency.
Evaluate global regulatory submission strategies, including sequencing, target markets, and associated risks and trade-offs.
Apply international guidelines, agreements, and reliance pathways—such as those from the International Council for Harmonization—to inform regulatory decision-making.
Analyze the structure and coordination of multi-region regulatory submissions and global lifecycle management requirements.
Create and communicate a comprehensive global regulatory strategy using professional formats aligned with industry expectations.

Course Information

Online

0.00 units

$795.00

Course sessions

Add To Cart 7/20/2026 - 9/28/2026 Online $795

Section ID:

199141

Class type:

Online Asynchronous.

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: 7/27/2026

Schedule:

No information available at this time.

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