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Unit of study_

PCOL5103: Therapeutics and Device Innovations (Project)

2022 unit information

This unit of study will provide students with the knowledge and skills to identify and evaluate complex technical problems and develop an implementation plan to address a problem. The unit will involve case studies from both pharmaceutical and medical device sectors, industry experts and application of international standards. Students will be given a problem from real life case studies and work through the steps to develop an implementation plan. In addition to submitting written reports, students will present their final implementation plan through recorded presentations.

Unit details and rules

Managing faculty or University school:

Pharmacy

Code PCOL5103
Academic unit Pharmacy
Credit points 6
Prerequisites:
? 
None
Corequisites:
? 
PCOL5101 or PCOL5102
Prohibitions:
? 
None
Assumed knowledge:
? 
None

At the completion of this unit, you should be able to:

  • LO1. Understand the importance of intellectual property protection in the commercialisation process of medical technologies and the different regulations that governs its protections
  • LO2. Summarise the processes in the application of a new invention and patent
  • LO3. Apply the principals of good clinical practice and good record keeping during the early phases of medical technology development
  • LO4. Design first in human clinical trials for therapeutics and medical devices
  • LO5. Evaluate and defend the scientific designs and claims of a new medical technology invention
  • LO6. Define the processes, documentations and regulatory requirements during the different phases of medical technology development.

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.
Session MoA ?  Location Outline ? 
Semester 1 2020
Online Camperdown/Darlington, Sydney
Semester 1 2021
Online Camperdown/Darlington, Sydney
Semester 1 2022
Online Camperdown/Darlington, Sydney

Modes of attendance (MoA)

This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.