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.
Details
Academic unit | Biomedical Engineering |
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Unit code | BMET3990 |
Unit name | Biomedical Product Development |
Session, year
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Semester 2, 2021 |
Attendance mode | Normal day |
Location | Remote |
Credit points | 6 |
Enrolment rules
Prohibitions
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AMME4990 or BMET4990 or AMME9990 or BMET9990 |
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Prerequisites
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MECH2901 or BMET2901 or [MEDS2005 and (MEDS2001 or PHSI2007)] |
Corequisites
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None |
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. |
Available to study abroad and exchange students | Yes |
Teaching staff and contact details
Coordinator | Colin Dunstan, colin.dunstan@sydney.edu.au |
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