Graduate Certificate in Pharmaceutical Regulation
GMS5003
Fundamentals of Health Products Regulation
(4 units)
This course lays the foundational basis of regulatory management and decision-making for health products, and covers the essential principles in managing pharmaceuticals and medical devices across their life cycles.
GMS5004
Regulation of Pharmaceutical Manufacturing
(4 units)
This course provides the foundation in understanding the regulatory science behind the development, manufacturing and control of pharmaceuticals, including the global guidances that shape the regulatory processes.
GMS5108
Clinical Studies & Evaluation of Health Products
(4 units)
This course will provide an overview of the design and phases of human clinical trials, as well as the regulatory requirements to support market approvals of pharmaceuticals, medical devices and technologies.
GMS5116
Post-Market Activities for Pharmaceuticals
(4 units)
This course will allow participants to understand the damaging implications of poor quality medicines to public health, as well as the evolving challenges in minimising the entry of these substandard medicines and falsified products.
Graduate Certificate in Medical Technology Regulation
GMS5008
Regulation and Clinical Evaluation of Medical Devices
(4 units)
This course describes the unique approaches for the product design and development, as well as regulation of medical devices and technology. Key concepts for assessing the clinical performance of medical devices will be introduced, facilitating the understanding of an optimal environment for health technology adoption.
GMS5009
Manufacturing and Quality Management System for Medical Devices
(4 units)
This course covers the production, quality management systems, and regulatory activities related to quality assurance of medical technology in regulated markets.
GMS5114
Post Market for Medical Technologies
(4 units)
This course aims to equip students with the knowledge of the post-market regulatory requirements of medical devices, and the activities involved in managing adverse events and conducting Field safety corrective action.
GMS5106
Regulation of Digital Health Products
(4 units)
Through this course, students will learn to describe and differentiate the relevant standards and guidance required in Digital Health products verification and validation.