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Unit of study_
PHAR7826: Advanced Therapies: Development and Regulation
2024 unit information
This unit will give students the skills to understand how advanced therapy products, such as cell and gene therapies, 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 registration of these types of products in Australia and globally.
Unit details and rules
Managing faculty or University school:
Medicine and Health
| Study level | Postgraduate |
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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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PCOL5102 |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. Explain the major milestones involved in the lifecycle of an advanced therapy product
- LO2. Evaluate and construct data package requirements for the registration of an advanced therapy product in Australia
- LO3. Perform activities associated with the role of the regulatory affairs specialist
- LO4. Integrate knowledge, skills and experience of cell and gene therapy product development and regulation using reflective practice
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 previous years.
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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.
