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Unit of study_
PCOL5102: Modern Therapeutics and Medical Devices
2023 unit information
This unit of study develops knowledge in advanced therapy medicinal products such as cell and gene therapies. The principles of mode of action are investigated, along with methods of manufacture and registration. This unit will give students the skills to understand how cell and gene therapy products are researched, developed and regulated. The regulatory requirements for chemistry, manufacturing and controls, pre-clinical testing including toxicity studies, and clinical testing will be discussed. Finally, the unit will examine the regulatory requirements for licensing and registration of these types of products in Australia and overseas. This unit is suitable for postgraduate students who are working in or interested in entering the biopharmaceutical industry or those developing new advanced therapy products.
Unit details and rules
Managing faculty or University school:
Pharmacy
| Code | PCOL5102 |
|---|---|
| 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. Understand the basic principles underpinning innovative therapies and medical devices
- LO2. Summarise the key regulatory requirements required in the development and registration of the different therapeutics and medical devices
- LO3. Define the general processes of manufacture, verification and validation testing to meet regulation requirements
- LO4. Evaluate the challenges associated with safety, manufacturing and production of medical devices and therapeutics
- LO5. Understand the application of pharmacogenomics, pharmacodynamics and pharmacokinetics in development of modern therapeutics and personalised medicines.
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.
