This unit of study develops knowledge in advanced therapy medicinal products such as cell and gene therapies. The principles of mode of action are investigated, along with methods of manufacture and registration. This unit will give students the skills to understand how cell and gene therapy products are researched, developed and regulated. The regulatory requirements for chemistry, manufacturing and controls, pre-clinical testing including toxicity studies, and clinical testing will be discussed. Finally, the unit will examine the regulatory requirements for licensing and registration of these types of products in Australia and overseas. This unit is suitable for postgraduate students who are working in or interested in entering the biopharmaceutical industry or those developing new advanced therapy products.
Unit details and rules
Academic unit | Pharmacy |
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Credit points | 6 |
Prerequisites
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None |
Corequisites
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None |
Prohibitions
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None |
Assumed knowledge
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None |
Available to study abroad and exchange students | No |
Teaching staff
Coordinator | Orin Chisholm, orin.chisholm@sydney.edu.au |
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Tutor(s) | Orin Chisholm, orin.chisholm@sydney.edu.au |