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Unit of study_

Pharm and Medical Device Development - PCOL5104

This capstone unit develops the critical thinking needed to transform a new therapeutic drug and/or 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

presentation of dossier submission strategy (20%), dossier submissions (50%), participation in discussion boards and webinars (20%) and reflective assessment (10%)

Online readings and other learning resources will be provided


CEPI5100 and 18 credit points of stream specific units of study


Faculty: Medicine and Health

Semester 2

05 Aug 2019

Department/School: Pharmaceutical and Medical Device Development
Study Mode: Distance education/intensive on campus
Census Date: 31 Aug 2019
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, Professor Paul Young, Professor Daniela Traini
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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