This unit provides a detailed overview of the processes involved in the development, production and regulation of complementary medicines and devices (with a focus on herbal and nutritional supplement products). In this unit, students will learn foundation concepts and principles of complementary medicines, the regulatory framework, relevant policies and ethical implications (including evidence claims) governing this industry, good manufacturing practice (GMP) and quality standards, submission of product dossiers requirements as well as internationalisation of complementary medicine products (e. g. regulation in Asia and other key areas for export). Students will gain an understanding of the processes and guidelines involved in registering complementary products with the Therapeutic Goods Administration (TGA) in Australia and will be able to assess the level and quality of evidence to support the manufacturer's claim. This unit is suitable for postgraduate students who are working in or interested in entering the complementary medicine development, manufacturing and regulation sector.
online lectures, podcasts, discussion boards, webinars, interactive media
online quizzes (20%), short answer questions/case studies (40%), written assignment(s) (40%)
Online resources, readings and other learning recourses will be provided or accessible via the Library
Students will be expected to have a relevant health care, health science or science related undergraduate qualification or experience working in this sector.