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Global medicines development: Fundamentals of regulatory affairs

GMD5001

Synopsis

 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.

Sourced from the Monash Handbook 2026.

Quick facts

Credit points
6
Level
5
Audience
Postgraduate
Type
Coursework
School
Faculty of Pharmacy and Pharmaceutical Sciences
Handbook year
2026

Prerequisites

No prereqs in the handbook graph.

What it unlocks

Nothing in the visible graph depends on this unit.

Offerings (1)

  • First semesterParkville · ONLINE