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Regulatory Affairs in Biotechnology (LAWS90195)
Graduate courseworkPoints: 12.5Not available in 2022
From 2023 most subjects will be taught on campus only with flexible options limited to a select number of postgraduate programs and individual subjects.
To learn more, visit COVID-19 course and subject delivery.
Overview
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Biotechnology products are subject to stringent regulatory and quality requirements and effective management of a biotechnology enterprise requires a sound understanding of these requirements. There are many examples where enterprises have failed due to a failure to attend to these requirements. Topics covered include the management of approval processes for new products through clinical trials and to commercial product; ongoing management of a registration dossier in a manufacturing environment including change control; strategies to accommodate differing requirements globally and the impact of new regulatory trends globally. The options for the assessment-based learning include three different specialist areas of biotechnology – therapeutics, medical devices and food & agriculture. Students will receive expert support in these areas to engage in active learning in completing the assessment tasks.
Intended learning outcomes
On completion of this subject, students should be able to:
- Manage approval processes from concept to market;
- Manage the registration dossier in a manufacturing environment;
- Manage development and manufacturing strategies to accommodate differences in Regulations globally;
- Investigate impact of trends and anticipate regulatory changes in a product development situation.
Generic skills
Graduates on successful completion of this subject will demonstrate:
- ability to demonstrate advanced independent critical enquiry;
- a strong sense of intellectual integrity and the ethics of scholarship;
- in-depth knowledge of their specialist discipline(s);
- a high level of achievement in writing, project activities, problem-solving and communication;
- the ability to critically examine issues, synthesise and evaluate knowledge across a broad range of disciplines;
- critical and creative thought, with an aptitude for continued self-directed learning;
- flexible and transferable skills for different types of employment.
Last updated: 12 November 2022
Eligibility and requirements
Prerequisites
The course coordinator will review the applicability of work experience of the applicants for this subject.
Corequisites
None
Non-allowed subjects
None
Recommended background knowledge
A general awareness of biotechnology development and/or manufacturing is recommended.
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: 12 November 2022
Assessment
Description | Timing | Percentage |
---|---|---|
Project management plan for regulatory affairs from concept to market
| From Week 1 to Week 3 | 27% |
Prepare a plan for regulatory affairs from lifecycle management of product and its manufacture in the marketplace. Include a section of managing the different regulatory requirements globally
| From Week 4 to Week 6 | 27% |
Project management plan to respond to proposed changes in regulation and quality issues
| From Week 7 to Week 8 | 27% |
Four multiple choice tests, 30 minutes duration each
| Weeks 2, 4, 6 & 8 | 19% |
Last updated: 12 November 2022
Dates & times
Not available in 2022
Last updated: 12 November 2022
Further information
- Texts
Prescribed texts
There are no specifically prescribed or recommended texts for this subject.
- 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: 12 November 2022