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

On completion of this subject, students should be able 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;
  • Identify the regulatory steps in international jurisdictions;
  • Communicate fluently and present arguments in oral and written form;
  • Collaborate effectively in small and large groups.

Generic skills

Students will develop:

  • aptitude for continued self-directed learning;
  • the ability to 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;
  • skills to evaluate and judge ideas and processes from disparate disciplines;
  • the ability to create and develop plans and strategies interfacing science, technology and commerce.

Last updated: 4 March 2025

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: 4 March 2025

Assessment

DescriptionTimingPercentage

4 x 30 minute in-class tests, one for each unit (10% each). Due in weeks 4, 6, 8 and 10.

  • 30 minutes (each)
Throughout the teaching period40%

One assignment for each of the 4 units (15% each). Due in weeks 4, 6, 8, 10. The assignments comprise of: 3 x individual written assignments, each 1,000 words (for three units) and 1 x group 10 minute oral/video presentation (based on one unit)

  • 3500 words
Throughout the teaching period and during assessment period60%

Attendance at greater than 80% of workshops throughout the semester.

Hurdle requirement		Throughout the semesterN/A

Last updated: 4 March 2025

Dates & times

  • Semester 2
    CoordinatorDaniel Czech
    Mode of deliveryOn Campus (Parkville)
    Contact hours32 hours comprising two 1-hour lectures per week and one 2-hour workshop per week over eight weeks.
    Total time commitment170 hours
    Teaching period28 July 2025 to 26 October 2025
    Last self-enrol date 8 August 2025
    Census date 1 September 2025
    Last date to withdraw without fail26 September 2025
    Assessment period ends21 November 2025

    Semester 2 contact information

Time commitment details

170 hours

What do these dates mean

Visit this webpage to find out about these key dates, including how they impact on:

  • Your tuition fees, academic transcript and statements.
  • And for Commonwealth Supported students, your:
       -  Student Learning Entitlement. This applies to all students enrolled in a Commonwealth Supported Place (CSP).
     

    Subjects withdrawn after the census date (including up to the ‘last day to withdraw without fail’) count toward the Student Learning Entitlement.

Last updated: 4 March 2025

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.

    Please note Single Subject Studies via Community Access Program is not available to student visa holders or applicants

    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: 4 March 2025