UnitLevel 5Postgraduate

GMD5001 Global medicines development: Fundamentals of regulatory affairs

Faculty of Pharmacy and Pharmaceutical Sciences

GMD5001 Global medicines development: Fundamentals of regulatory affairs is a level 5, 6-credit-point, postgraduate unit from the Faculty of Pharmacy and Pharmaceutical Sciences, offered in 2027 in Semester 1 at Parkville. It has no prerequisites.

Credit points: 6
Offered in 2027: Semester 1; Parkville
Assessment: No exam; 4 tasks
Workload: 144 hours; per semester

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Requisites

Before GMD5001

No prerequisites or corequisites besides the enrolment rules below.

After GMD5001

No unit lists GMD5001 as a prerequisite in the 2027 handbook.

Enrolment rules

Must be enrolled in P6006 Master of Global Medicines Development.

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 in 2027

Teaching period	Campus	Mode
First semester	Parkville	Online

Assessment

Discussion BoardExercise
20%
QuizzesQuiz / Test
40%
Longitudinal ProjectArtefact
20%
Final asssessmentProject
20%

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

Learning outcomes

When you finish this unit, you should be able to:

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 and teaching

Teaching approachEnquiry-based learning
Teaching approachOnline learning
Teaching approachActive learning
Teaching approachCase-based teaching

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.

Learning resources

Required resources

Students will be supplied required resources in Canvas (UNC LMS)

Technology resources

For more information on Bring Your Own Device (BYOD) specifications and the technology systems and services available to students, review the Student Technology Essentials Handbook

Contacts

Unit Coordinators: Dr Tony Hughes
Chief Examiners: Dr Tony Hughes

Common questions

What are the prerequisites for GMD5001?

GMD5001 has no prerequisites, but enrolment rules apply.

When is GMD5001 offered?

In 2027, GMD5001 runs in Semester 1 at Parkville, with an online option.

How much work is GMD5001?

The handbook expects about 144 hours of study across the semester. No students have rated its difficulty yet.

Does GMD5001 have an exam?

No. GMD5001 has 4 assessment tasks and no exam.

More details

Credit points: 6
Level: 5
Study level: Postgraduate
Faculty: Faculty of Pharmacy and Pharmaceutical Sciences

Type: Coursework
EFTSL: 0.125
Student contribution: SCA Band 2
Study abroad: Not available
Handbook years: 20262027