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Unit of study_

Pharm and Medical Device Development - PCOL5104

Year - 2018

This capstone unit develops the critical thinking needed to transform a new therapeutic drug 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 work in groups to determine the submission strategy and assign individual components where each student solves a clinical/scientific question related to one core aspect of the process (i.e. manufacturing, stability, clinical trial or other suitable component of the process). The group will meet at the face to face workshop to compile the dossier before presenting tho their peers and industry experts.

discussion forums and webinars plus compulsory face to face workshop.

group dossier submission strategy (20%), individual submissions (40%), participation in discussion boards and webinars (20%) and group presentation at workshop (20%)

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

30 Jul 2018

Department/School: Pharmaceutical and Medical Device Development
Study Mode: Distance education/intensive on campus
Census Date: 31 Aug 2018
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: Professor Paul Young, Dr Hui Xin Ong, 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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