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Unit of study_
BMET4990: Biomedical Product Development
Product development in the biomedical area presents unique challenges that need to be addressed to efficiently satisfy strict regulatory requirements and to successfully advance products to approval for marketing. Biomedical engineers need a broad understanding of these challenges as the main components of product development are complex and interdependent. Development of good manufacturing and quality control processes, preclinical and clinical validation of product safety and efficacy, and regulatory filings, are each progressive and interdependent processes. This UoS will provide a broad understanding of regulatory requirements for biomedical product development, with particular emphasis on the dependence of each component on the development of processes and control systems that conform to Good Manufacturing Practice. This UoS assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development.
| Code | BMET4990 |
|---|---|
| Academic unit | Biomedical Engineering |
| Credit points | 6 |
|
Prerequisites:
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MECH2901 OR BMET2901 |
|---|---|
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Corequisites:
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None |
| Prohibitions:
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AMME4990 |
| Assumed knowledge:
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1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level. |
At the completion of this unit, you should be able to:
- LO1. demonstrate expertise in working in a team environment to develop a medical product concept and a plan for its implementation in conformity with regulatory guidelines
- LO2. demonstrate a broad understanding of biomedical product development within the regulatory framework
- LO3. present a complex plan for development of a drug or medical device to initial testing in human subjects
- LO4. understand the purpose and conduct of preclinical and clinical testing
- LO5. develop manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice.
Unit outlines
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