Sydney Professional Certificate

Complementary Medicines Regulation

Graduates of this Professional Certificate will have specialised knowledge in the Complementary Medicines Regulation.

Graduates will have cognitive skills to:

  • Understand the processes involved in the development, production, regulation and ethics of pharmaceutical products and devices with a focus on the complementary medicines industry.
  • Discussion of good manufacturing practice (GMP), quality standards and submission of product dossiers requirements for complementary medicines in Australia.
  • Evaluate the ethical aspects of medicine and device marketing with a special focus on assessing the level and quality of evidence to support the manufacturer’s claim for herbal and nutritional supplement products in Australia.
  • Appraise the internationalisation of complementary medicine products. for example regulation in Asia and other key areas for export.

 
 

Unit of study Credit points A: Assumed knowledge P: Prerequisites C: Corequisites N: Prohibition Session

Sydney Professional Certificate in Complementary Medicines Regulation

Students must complete:
(a) 12 credit points of 5000-level and 7000-level units of study
PCOL5101
Drugs and Devices: R and D to Registration
6      Semester 1
PHAR7815
Regulation of Complementary Medicines
6    A Students will be expected to have a relevant health care, health science or science related undergraduate qualification or experience working in this sector.
Semester 1

Sydney Professional Certificate in Complementary Medicines Regulation

Students must complete:
(a) 12 credit points of 5000-level and 7000-level units of study
PCOL5101 Drugs and Devices: R and D to Registration

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong & Dr Rania Salama Session: Semester 1 Classes: online lectures, podcasts, discussion boards, webinars Assessment: online quizzes (20%), short answer questions (20%) written assignments (30%), presentation (15%); case study (15%) Mode of delivery: Online
This unit of study provides a broad overview of the processes involved in translating a new drug, formulation and/or medical device from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical or medical device industries, and advisors in the regulatory sector. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery and device conception, manufacture and clinical trials, and (3) post-registration pharmacovigilance and pharmacoeconomics . 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 covers 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 and medical device documentation. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics, pharmacoeconomics 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.
Textbooks
online readings and other learning resources will be provided.
PHAR7815 Regulation of Complementary Medicines

Credit points: 6 Teacher/Coordinator: Dr Joanna Harnett, Dr Rania Salama, Dr Hui Xin Ong Session: Semester 1 Classes: online lectures, podcasts, discussion boards, webinars, interactive media Assumed knowledge: Students will be expected to have a relevant health care, health science or science related undergraduate qualification or experience working in this sector. Assessment: online quizzes (20%), short answer questions/case studies (40%), written assignment(s) (40%) Mode of delivery: Online
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.
Textbooks
Online resources, readings and other learning recourses will be provided or accessible via the Library