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Unit of study_

Drugs and Devices: R and D to Registration - PCOL5101

This unit of study provides a broad overview of the processes involved in translating a new drug, formulation and/or pharmaceutical delivery device from a laboratory setting to a final approved product. It is targeted at people in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery, manufacture and clinical trials, and (3) post-registration pharmacovigilance and pharmacoeconomics. Students will gain knowledge of the Therapeutic Goods Administration (TGA) and guidelines for the registration and regulation of medical devices and medicines. Students will also learn the importance of international regulations, harmonisation and application to the Australian market. The unit will also cover R and D; manufacturing and clinical trial requirements; the concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD); as well as regulator accepted laboratory methodologies used for submission of product dossiers. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics, pharmacoeconomics and clinical endpoints for registration of new products using case studies and online tutorials. Special requirements for the registration and testing of generic medicines will also be part of the unit.

online lectures, podcasts, discussion boards, webinars

online quizzes (20%), short answer questions (20%) written assignments (45%), presentations(15%)

online readings and other learning resources will be provided.


Faculty: Medicine and Health

Semester 1

25 Feb 2019

Department/School: Pharmaceutical and Medical Device Development
Study Mode: Online
Census Date: 31 Mar 2019
Unit of study level: Postgraduate
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: No
Faculty/department permission required? No
More details
Unit of Study coordinator: Dr Hui Xin Ong, Dr Rania Salama, Prof Paul Young, Prof Daniela Traini
HECS Band: 2
Courses that offer this unit

Non-award/non-degree study If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student. Cross-institutional study If you are from another Australian tertiary institution you may be permitted to undertake cross-institutional study in one or more units of study at the University of Sydney.

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