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Regulation of Biotechnology (LAWS90003)
Graduate courseworkPoints: 12.5On Campus (Parkville)
For information about the University’s phased return to campus and in-person activity in Winter and Semester 2, please refer to the on-campus subjects page.
About this subject
- Overview
- Eligibility and requirements
- Assessment
- Dates and times
- Further information
- Timetable(opens in new window)
Contact information
Semester 2
Please refer to the LMS for up-to-date subject information, including assessment and participation requirements, for subjects being offered in 2020.
Overview
Availability | Semester 2 |
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Fees | Look up fees |
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
To:
- 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.
Generic skills
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.
Last updated: 3 November 2022
Eligibility and requirements
Prerequisites
None
Corequisites
None
Non-allowed subjects
None
Inherent requirements (core participation requirements)
The University of Melbourne is committed to providing students with reasonable adjustments to assessment and participation under the Disability Standards for Education (2005), and the Assessment and Results Policy (MPF1326). Students are expected to meet the core participation requirements for their course. These can be viewed under Entry and Participation Requirements for the course outlines in the Handbook.
Further details on how to seek academic adjustments can be found on the Student Equity and Disability Support website: http://services.unimelb.edu.au/student-equity/home
Last updated: 3 November 2022
Assessment
Due to the impact of COVID-19, assessment may differ from that published in the Handbook. Students are reminded to check the subject assessment requirements published in the subject outline on the LMS
Additional details
Four 30 minute in-class tests, one for each unit, during semester: 40%
Four group assignments, one for each unit, with each individual contributing the equivalent of 750 words for each assignment, during semester: 60%
Last updated: 3 November 2022
Dates & times
- Semester 2
Principal coordinator Richard Buchta Mode of delivery On Campus (Parkville) Contact hours Eight 4-hour workshops, two workshops for each unit. Total time commitment 170 hours Teaching period 3 August 2020 to 1 November 2020 Last self-enrol date 14 August 2020 Census date 21 September 2020 Last date to withdraw without fail 16 October 2020 Assessment period ends 27 November 2020 Semester 2 contact information
Time commitment details
170 hours
Last updated: 3 November 2022
Further information
- Texts
Prescribed texts
There are no specifically prescribed or recommended texts for this subject.
- Related Handbook entries
This subject contributes to the following:
Type Name Course Master of Biotechnology - Links to additional information
- Available through the Community Access Program
About the Community Access Program (CAP)
This subject is available through the Community Access Program (also called Single Subject Studies) which allows you to enrol in single subjects offered by the University of Melbourne, without the commitment required to complete a whole degree.
Entry requirements including prerequisites may apply. Please refer to the CAP applications page for further information.
- Available to Study Abroad and/or Study Exchange Students
This subject is available to students studying at the University from eligible overseas institutions on exchange and study abroad. Students are required to satisfy any listed requirements, such as pre- and co-requisites, for enrolment in the subject.
Last updated: 3 November 2022