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Unit of study_
PCOL5104: Pharm and Medical Device Development
2022 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 in order to prepare sections of the final scientific dossier that would be suitable for submission to the TGA, EMA or FDA. Students will determine the submission strategy and solve clinical/scientific issues related to core aspects of the process (i.e. chemistry, manufacturing, quality, stability, safety, clinical trial or other suitable component of the process).
Unit details and rules
Managing faculty or University school:
Pharmacy
| Code | PCOL5104 |
|---|---|
| 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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CEPI5100 and 18 credit points of stream specific units of study from any of (PCOL5101, PCOL5102, PCOL5103, PCOL5105, PHAR7815) |
| 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. Identify and outline the requirements for compiling the Common Technical Document (CTD) for pharmaceuticals and Market Authorisation approval document for a medical device
- LO2. Explain the purpose, regulatory requirements and regional differences for the Common Technical Document and Market Authorisation submissions according to the latest guidelines
- LO3. Critically appraise available data and literature for relevance to the regulatory submission
- LO4. Systematically compile pertinent data into a final dossier for submission to the regulatory body
- LO5. Understand and compare the regulatory processes for traditional and unconventional medicinal products and medical devices
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)
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