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Unit of study_

Regulation of Complementary Medicines - PHAR7815

Year - 2020

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.

Classes
online lectures, podcasts, discussion boards, webinars, interactive media

Assessment
online quizzes (20%), short answer questions/case studies (40%), written assignment(s) (40%)

Textbooks
Online resources, readings and other learning recourses will be provided or accessible via the Library

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.

Details

Faculty: Medicine and Health

Semester 1

24 Feb 2020

Department/School: Pharmacy
Study Mode: Online
Census Date: 31 Mar 2020
Unit of study level: Postgraduate
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: No
Faculty/department permission required? No
Location
Camperdown
More details
Unit of Study coordinator: Dr Joanna Harnett, Dr Rania Salama, Dr Hui Xin Ong
HECS Band:
Courses that offer this unit

Non-award/non-degree study If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student. Cross-institutional study If you are from another Australian tertiary institution you may be permitted to undertake cross-institutional study in one or more units of study at the University of Sydney.

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