Biomedical Product Development (AMME4990)
UNIT OF STUDY
Elective Unit of Study: 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.
Further unit of study information
Lecture 2 hrs/week; Tutorial 2 hrs/week; Independent Study,
Through semester assessment (100%)
Faculty/department permission required?
Unit of study rules
Prerequisites and assumed knowledge
BIOL1003 OR 6 credit points of junior biology CHEM1101 OR 6 credit points of junior chemistry MECH2901 OR 6 credit points of junior intermediate physiology or equivalent, MECH3921.
Junior level chemistry, intermediate level biology, and specific knowledge of cell biology at least at the junior level, and preferably at the intermediate level.
Study this unit outside a degree
If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student.
If you are from another Australian tertiary institution you may be permitted to underake cross-institutional study in one or more units of study at the University of Sydney.