VCF2101

Product development II

(PHA)

Dr Barrie Finnin

25 hours lectures, workshops and self-learning modules, 25 tutorials

Synopsis: The Therapeutic Goods Act and relevant regulations and orders, the Therapeutic Goods Administration, the Therapeutic Goods Register and the process of Listing and Registration, requirements for applications for listing and registration, the Electronic Lodgement Facility, international registration requirements and procedures. Physical and chemical product specifications, quality control procedures and test methods, stability testing

Assessment: Self-learning modules: 15% + Workshop projects: 45% + End-of-year examination: 40%