Regulatory Affairs - PHAR9104

Faculty: Faculty of Medicine

School: School of Medical Sciences

Course Outline:

Campus: Sydney

Career: Postgraduate

Units of Credit: 6

EFTSL: 0.12500 (more info)

Indicative Contact Hours per Week: 10

CSS Contribution Charge: 1 (more info)

Tuition Fee: See Tuition Fee Schedule

Further Information: See Class Timetable

View course information for previous years.


PLEASE NOTE: This course has had a change of code and title - up to and including 2009, the course code was PHPH9104. Up to and including 2016, the course title was Law, Ethics and the Regulation of Medicines.

Regulatory Affairs is responsible for ensuring the company remains compliant with all legislation and regulations pertaining to the function of the company in a particular jurisdiction. This course will provide an introduction to the regulation of therapeutic products, with particular reference to the Australian context. It will introduce students to the Australian legal system within which the regulation of therapeutic products occurs. This course will conclude by exploring pharmaceutical ethics and the ethics of the regulation of therapeutic products.

Note: The course is compulsory for programmes 7370, 5504, 9060. This course is one of two options for the compulsory Regulatory Affairs component for programmes 5371 and 9370.
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