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Unit of study_

Pharm and Medical Device Development - PCOL5104

Year - 2020

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).

online discussion forums, webinars

2 x 500 wd written assignments (10%), recorded presentation and peer review (20%), 2 x 3000 wd dossier sections submission and peer review (70%)

Online readings and other learning resources will be provided


CEPI5100 and 18 credit points of stream specific units of study from any of (PCOL5101, PCOL5102, PCOL5103, PCOL5105, PHAR7815)


Faculty: Medicine and Health

Semester 2 Early

03 Aug 2020

Department/School: Pharmaceutical and Medical Device Development
Study Mode: Online
Census Date: 31 Aug 2020
Unit of study level: Postgraduate
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: No
Faculty/department permission required? No
More details
Unit of Study coordinator: Dr Hui Xin Ong & Dr Rania Salama
HECS Band: 2
Courses that offer this unit

Non-award/non-degree study If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student. Cross-institutional study If you are from another Australian tertiary institution you may be permitted to undertake cross-institutional study in one or more units of study at the University of Sydney.

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