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Prototypes, Field & Clinical Trials (BTCH90011)
Graduate courseworkPoints: 12.5Not available in 2024
Overview
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|---|
Biotechnology enterprises are reliant on new product introduction to maintain competitiveness. New product introduction involves prototyping and/or clinical trials. This subject will enable students to establish capability in the management of testing new products, prototyping, and field and clinical trials. The subject will cover a range of topics including design briefs; target product profiles; prototype development and testing; good regulatory practices and optimally efficient approaches to ensure product under development meets customer needs. 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
Upon completion of this subject students should be able to:
- Develop a design brief or target product profile (TPP) for a product to meet a customer need;
- Develop programs for prototype development which assess and meet customer/market satisfaction;
- Employ good regulatory practices and optimally efficient approaches in prototyping programs;
- Finalise design of product based on prototyping.
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;
- 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.
Last updated: 31 January 2024
Eligibility and requirements
Prerequisites
None
Corequisites
None
Non-allowed subjects
None
Recommended background knowledge
A general awareness of biotechnology development is recommended.
Inherent requirements (core participation requirements)
The Faculty of Science welcomes applications from students with disabilities. The University is dedicated to providing support to those with special requirements. Further details can be found at the Student Equity and Disability Support website: http://www.services.unimelb.edu.au/disability/
A prospective student with a disability is advised to discuss with Student Equity and Disability Support any issues related to his or her ability to successfully meet all the course requirements.
Appropriate adjustments will be made to enhance the participation of students with a disability. For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education, and Students Experiencing Academic Disadvantage Policy, academic requirements for this course are articulated in the Course Description, Course Objectives and Generic Skills of this entry.
Last updated: 31 January 2024
Assessment
| Description | Timing | Percentage |
|---|---|---|
Design brief/TPP for development of a product
| From Week 1 to Week 2 | 20% |
Written report: strategy for prototype development from concept to transfer manufacturing
| From Week 3 to Week 4 | 20% |
Written report: address regulatory issues for the protype development and the options for making the program optimally efficient
| From Week 5 to Week 6 | 20% |
Written report: close out for development, transfer to commercial manufacturing
| From Week 7 to Week 8 | 20% |
Four multiple-choice tests, 30 minutes duration each (5% each quiz)
| Weeks 2, 4, 6 & 8 | 20% |
Last updated: 31 January 2024
Dates & times
Not available in 2024
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: 31 January 2024
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: 31 January 2024