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Unit of study_
PCOL5101: Drugs and Devices: R and D to Registration
2022 unit information
This unit of study provides a broad overview of the processes involved in translating a new drug, formulation and/or medical device from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical or medical device industries, and advisors in the regulatory sector. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery and device conception, 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 covers 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 and medical device documentation. 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.
Unit details and rules
Managing faculty or University school:
Pharmacy
| Code | PCOL5101 |
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| Academic unit | Pharmacy |
| Credit points | 6 |
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Prerequisites:
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None |
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Corequisites:
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None |
| Prohibitions:
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None |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. Summarise the processes and path for taking a new therapeutic or medical device from conception through to registration
- LO2. Define the processes and steps that are required with respect to the local regulatory environment and how this differs from the requirements of overseas regulatory systems
- LO3. Define the process requirements during discovery, manufacture, clinical trial and registration
- LO4. Apply the principles of good record keeping in preparing an R and D dossier
- LO5. Evaluate the ethical aspects of medicine and device marketing
- LO6. Define the post registration obligations of registered products.
Unit availability
This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.
The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.
There are no availabilities for this year.
Modes of attendance (MoA)
This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.
