Regulatory Affairs in Biotechnology (LAWS90195)

Biotechnology products are subject to stringent regulatory and quality requirements and effective management of a biotechnology enterprise requires a sound understanding of these requirements. There are many examples where enterprises have failed due to a failure to attend to these requirements. Topics covered include the management of approval processes for new products through clinical trials and to commercial product; ongoing management of a registration dossier in a manufacturing environment including change control; strategies to accommodate differing requirements globally and the impact of new regulatory trends globally. The options for the assessment-based learning include three different specialist areas of biotechnology – therapeutics, medical devices and food & agriculture. Students will receive expert support in these areas to engage in active learning in completing the assessment tasks.