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Regulation of Biotechnology (LAWS90003)

Graduate courseworkPoints: 12.5On Campus (Parkville)

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Overview

Availability
Semester 2
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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

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 coordinatorMatthew Digby
    Mode of deliveryOn Campus (Parkville)
    Contact hoursEight 4-hour workshops, two workshops for each unit.
    Total time commitment170 hours
    Teaching period24 July 2017 to 22 October 2017
    Last self-enrol date 4 August 2017
    Census date31 August 2017
    Last date to withdraw without fail22 September 2017
    Assessment period ends17 November 2017

    Semester 2 contact information

    mdigby@unimelb.edu.au

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:

    TypeName
    CourseMaster of Biotechnology
  • Links to additional information

    http://graduate.science.unimelb.edu.au/

  • 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