|Year of offer||2018|
|Subject level||Graduate coursework|
|Fees||Subject EFTSL, Level, Discipline & Census Date|
The successful commercialisation and marketing of biotechnological products requires extensive documentation and rigorous evaluation by the relevant regulatory bodies.
This subject is comprised of four discreet units focusing on: the Australian Pesticides and Veterinary Medicines Authority (APVMA) Office of the Gene Technology Regulator (OGTR) Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ) and their international counterparts such as the USA Food and Drug Administration (FDA).
The regulatory requirements of devices, drugs and foods will be examined by a series of case study focused seminars and workshops, providing an understanding of the time frame, rigor, effort, and uncertainty encountered throughout the process of product registration.
Intended learning outcomes
- Identify the appropriate regulatory body for a particular product and market
- Understand the timeframe and technical requirements of the relevant regulatory agency
- Plan for successfully satisfying the appropriate agency
- Relate the stringency and expense of registration to the market and projected sales
- Understand the regulatory steps in international jurisdictions.
Students will develop:
- aptitude for continued self-directed learning
- examine critically, synthesise and evaluate knowledge across a broad range of disciplines
- their analytical and cognitive skills through learning experiences in diverse subjects
- a capacity to participate fully in collaborative learning and to confront unfamiliar problems
- evaluate and judge ideas and processes from disparate disciplines
- create and develop plans and strategies interfacing science, technology and commerce.