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 a 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, stability, safety, clinical trial or other suitable component of the process).
Unit details and rules
Academic unit | Pharmaceutical and Medical Device Development |
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Credit points | 6 |
Prerequisites
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None |
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 |
Available to study abroad and exchange students | No |
Teaching staff
Coordinator | Rania Salama, rania.salama@sydney.edu.au |
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Tutor(s) | Hui Ong, ong.hui@sydney.edu.au |