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Unit of study_
PHAR7817: Pharmaceuticals: Development and Regulation
2024 unit information
This unit of study provides a broad overview of the processes involved in translating a new pharmaceutical product from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical industry. This unit will give students the skills to understand how medicines 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 legal and regulatory requirements for registration of these types of products.
Unit details and rules
Managing faculty or University school:
Pharmacy
| Code | PHAR7817 |
|---|---|
| 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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PCOL5101 |
| 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 a pharmaceutical product
- LO2. Evaluate and construct data package requirements for the registration of a pharmaceutical product in Australia
- LO3. Perform activities associated with the role of the regulatory affairs specialist
- LO4. Integrate knowledge, skills and experience of pharmaceutical 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.
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.
