This unit of study provides a broad overview of the process of translating a new drug, formulation and/or pharmaceutical delivery device from a laboratory setting to a final approved product. It is targeted at people in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery, manufacture and clinical trials, and (3) post-registration pharmacovigilance. Students will gain knowledge of the Therapeutic Goods Administration (TGA) and guidelines for the registration and regulation of medical devices and medicines. Students will also learn the importance of international regulations, harmonisation and application to the Australian market. The unit will also cover R and D; manufacturing and clinical trial requirements; the concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD); as well as regulator accepted laboratory methodologies used for submission of product dossiers. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics and clinical endpoints for registration of new products using case studies and online tutorials. Special requirements for the registration and testing of generic medicines will also be part of the unit.
Online lectures, podcasts, discussion boards, webinars
Online quizzes (20%), short answer questions (20%) written assignments (45%), presentations(15%)
online readings and other learning resources will be provided.