This unit will give students the skills to understand how advanced therapy products, such as cell and gene therapies, 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 registration of these types of products in Australia and globally.
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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PCOL5102 |
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) | Philip Kwok, philip.kwok@sydney.edu.au |