GMD5001 · Global medicines development: Fundamentals of regulatory affairs

Overview

This foundational pharmaceutical science unit will provide an overview of regulatory affairs with a focus on global pharmaceutical product development. You will learn about medical product regulation in major international markets including US, Europe, United Kingdom, Japan, and Australia. You will also learn about the process for obtaining and maintaining global marketing approvals along with tools and approaches used by regulatory professionals. This graduate-level unit will be taught asynchronously but will include regular touch points with unit instructors and other students.

Offerings

Assessment

The Handbook does not list a final examination among the assessment items. That is not a guarantee there is none.

In-semester assessment: 100%

Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.

Requisites

The Handbook lists no prerequisite, corequisite or prohibition for this unit.

Learning outcomes

1. Describe the origins of laws and regulations related to medical products in the US, Europe, UK, Japan, and Australia
2. Recognize the key international authorities, organizations, and standards involved in the regulation of medical products
3. Describe the differences between the types and subtypes of drugs, biologics, and medical devices
4. Summarize critical international regulations and regulatory documents impacting medical products
5. Explain how regulatory professionals support product development teams to bring new medical products to international markets
6. Explain how regulatory professionals support post-market compliance with FDA, EMA, MHRA, PMDA, and TGA regulatory requirements.

Workload

Minimum total expected workload to achieve the learning outcomes for this unit is 144 hours per semester typically comprising a mixture of online learning activities and independent study. The unit requires on average 10-12 hours of learning activities per week, including teacher directed learning, independent study and reading time, participation in online discussions, research and preparation for assignments.

Student experience, not official rules. Nothing here changes what the Handbook says.