Monash University

Leader(s): Dr Ben Boyd

Offered

Parkville Second semester 2009 (Day)

Synopsis

This unit will cover:

• the Therapeutic Goods Act and relevant regulations and orders
• the Therapeutic Goods Administration
• the Therapeutic Goods Register and the process of Listing and Registration requirements for applications for listing and registration
• the Electronic Lodgement Facility, international registration requirements and procedures
• physical and chemical product specifications, quality control procedures and test methods, stability testing.

Students are expected to spend some time in the industry on an individual basis and to attend group visits at a selection of industrial sites.

Objectives

Students will develop an:

1. Understanding of the regulation of therapeutic goods in Australia and of the process of gaining approval for marketing of therapeutic goods;
2. Ability to prepare specifications for a drug product and to design a stability study to support drug registration;
3. Appreciation of the control of manufacturing conditions for therapeutic goods including the Code of GMP.

Assessment

Various during semester and an end of semester examination

Prerequisites

PSC1042 (or VPS1042) Introduction to pharmaceutical sciences

Additional information on this unit is available from the faculty at:

http://muso.monash.edu.au/webct/entryPage.dowebct