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Unit of study_
PHAR7824: Pharmaceutical and Medical Device Development
2024 unit information
This capstone unit develops the critical thinking needed to transform a new therapeutic drug or a device into a commercially viable product. Students will critically appraise scientific and clinical data and information to prepare the early-stage development, pre-clinical, clinical and regulatory strategies for approval by either the TGA or another regulatory jurisdiction, as well as the reimbursement submission strategy for Australia or relevant jurisdiction.
Unit details and rules
Managing faculty or University school:
Pharmacy
| Code | PHAR7824 |
|---|---|
| Academic unit | Pharmacy |
| Credit points | 6 |
|
Prerequisites:
?
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None |
|---|---|
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Corequisites:
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18 credit points of stream specific units of study |
| Prohibitions:
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PCOL5104 |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. Critically appraise available scientific and clinical data and literature for a therapeutic area
- LO2. Develop and justify an early‐stage pre‐clinical and clinical strategy for a new therapeutic product to treat or diagnose a disease
- LO3. Develop and justify a global regulatory strategy for a new therapeutic product to treat or diagnose a disease
- LO4. Develop and justify a reimbursement strategy for a new therapeutic product to treat or diagnose a disease
- LO5. Integrate knowledge, skills and experience of therapeutic product development, regulation and reimbursement 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.
| Session | MoA ? | Location | Outline ? |
|---|---|---|---|
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Semester 2 2024
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Online | Camperdown/Darlington, Sydney |
Outline unavailable
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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.
