Course Title: Drug Regulations

Part A: Course Overview

Course Title: Drug Regulations

Credit Points: 12.00


Course Code




Learning Mode

Teaching Period(s)


Bundoora Campus


160H Medical Sciences


Sem 2 2006,
Sem 2 2007,
Sem 2 2008,
Sem 2 2009,
Sem 2 2010,
Sem 2 2011,
Sem 2 2012,
Sem 2 2013,
Sem 2 2015,
Sem 2 2016


Bundoora Campus


173H School of Health and Biomed


Sem 2 2017,
Sem 2 2018,
Sem 2 2019,
Sem 2 2020,
Sem 2 2021

Course Coordinator: Dr Celine Valery

Course Coordinator Phone: +61 3 9925 7482

Course Coordinator Email:

Course Coordinator Location: 201.02.038

Course Coordinator Availability: By Appointment

Pre-requisite Courses and Assumed Knowledge and Capabilities

Required prior study (Pre-requisites)


Course Description

The course will provide an understanding of the regulation of therapeutic goods and medical devices in Australia by the Therapeutic Goods Administration. The emphasis will be on drug regulations and associated ethics, and pre-marketing and post-marketing of drugs.

Objectives/Learning Outcomes/Capability Development

This course contributes to the following Program Learning Outcomes for the Bachelor of Pharmaceutical Sciences:

  • Critically analyse and solve scientific problems (PLO 2)
  • Communication and teamwork (PLO 3)
  • Investigation and analysis (PLO 4)

On successful completion of this course you should be able to:

  1. Search, review and analyse the scientific literature in the field;
  2. Advance arguments and develop skills in public speaking and work effectively in a team environment;
  3. Identify key factors in the regulation of therapeutic goods in Australia, including in the registration and manufacture of prescription & non-prescription pharmaceuticals and medical devices;
  4. Adapt knowledge to the application and approval processes of prescription and non-prescription pharmaceuticals and listed products;
  5. Identify key factors in health economics, pharmacovigilance and regulations regarding marketing and advertising of pharmaceuticals;
  6. Apply judgement to the Australian and Global perspective of drug regulations and the pharmaceutical industry.


Overview of Learning Activities

This course is designed to assist in the preparation of graduates for employment as responsible workers in the pharmaceutical industry or related government areas, or to pursue postgraduate clinical research in pharmacology or toxicology. External experts from industry will participate in the presentation of the course material and by so doing ensure that the course is relevant to the workplace, thus enhancing the employability of graduates. The syllabus is covered in a program of lectures, team work on a project and workshops designed to facilitate the acquisition of knowledge in the regulation of therapeutic goods in both an international and national context. Students will be presented with practical industry-based situations for analysis and evaluation in assignments that will encourage them to be creative and critical in their resolution of the problems presented.

Face-to-face learning: four (4) hours per week for one semester comprising lectures and workshops or team work.

Independent study: two (2) hours per week for one semester, including analysing articles, working on project, and revising lectures.

Overview of Learning Resources

Students will need to access the MyRMIT site for this course on the internet. Course material, assignments and tutorial activities will be available through MyRMIT. Students will also be expected to download refereed articles and references from the internet.

Overview of Assessment

This course has no hurdle requirements.

Assessment Tasks

Assessment Task 1: Online quizzes
Weighting 10%
This assessment task supports CLOs 3, 4, & 5 & 6

Assessment Task 2: Project (team work)
Weighting 35%
Includes team reports (25%) and individual presentation (10%)
This assessment task supports CLOs 1, 2, 3, 4, 5 & 6

Assessment Task 3: In-semester assessments
Weighting 40%
This assessment task supports CLOs 3 & 4

Assessment Task 4: Reflection essay
Weighting 15%
This assessment supports CLO 2