This unit of study develops knowledge in current state-of-the-art therapeutic technologies. The principles of mode of action are investigated, along with methods of manufacture and registration. The unit is targeted at people in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. It covers 4 core areas, reflecting different aspects of medicines regulation in Australia: (1) biologicals and personalised medicine, (2) cell based products, (3) medical devices and (4) classical formulations. The principles that underpin these innovative therapies are covered in terms of development, targeting and manufacture along with the application of genomics in personalised medicine. Students will investigate the processes of manufacture, verification and validation testing to ensure regulations are met. Cellular immunotherapy for cancer treatment is an emerging area. Students will gain knowledge of the different types of therapies within this space. Registration of medical devices will be covered. Case studies will be evaluated, including the challenges associated with bringing these therapies and devices to market. Classical formulations (i.e. oral, repiratory and injectable dosage forms) will be covered and advances within the field such as regulation of nanotechnology will also be discussed.
online lectures, podcasts, discussion boards, webinars
online quizzes (20%), short answer questions (20%), written assignments (45%),presenttions (15%)
online readings and other learning recourses will be provided.