Course Title: Drug Regulations

Part A: Course Overview

Course Title: Drug Regulations

Credit Points: 12.00

Terms

Course Code

Campus

Career

School

Learning Mode

Teaching Period(s)

ONPS2306

Bundoora Campus

Undergraduate

160H Medical Sciences

Face-to-Face

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

ONPS2306

Bundoora Campus

Undergraduate

173H School of Health and Biomed

Face-to-Face

Sem 2 2017,
Sem 2 2018,
Sem 2 2019,
Sem 2 2020,
Sem 2 2021,
Sem 2 2022,
Sem 2 2023

Course Coordinator: Dr Celine Valery

Course Coordinator Phone: +61 3 9925

Course Coordinator Email: celine.valery@rmit.edu.au

Course Coordinator Location: -

Course Coordinator Availability: By Appointment


Pre-requisite Courses and Assumed Knowledge and Capabilities

Required Prior Study

You should have satisfactorily completed following course/s before you commence this course.

Alternatively, you may be able to demonstrate the required skills and knowledge before you start this course.

Contact your course coordinator if you think you may be eligible for recognition of prior learning.


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)

 


Upon successful completion of this course, you will 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

You will be actively engaged in a range of learning activities such as lectorials, tutorials, practicals, laboratories, seminars, project work, class discussion, individual and group activities. Delivery may be face to face, online or a mix of both.

You are encouraged to be proactive and self-directed in your learning, asking questions of your lecturer and/or peers and seeking out information as required, especially from the numerous sources available through the RMIT library, and through links and material specific to this course that is available through myRMIT Studies Course.


Overview of Learning Resources

RMIT will provide you with resources and tools for learning in this course through myRMIT Studies Course.

There are services available to support your learning through the University Library. The Library provides guides on academic referencing and subject specialist help as well as a range of study support services. For further information, please visit the Library page on the RMIT University website and the myRMIT student portal.


Overview of Assessment

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%
This assessment task supports CLOs 1, 2, 3, 4, 5 & 6

Assessment Task 3: End of semester assessment
Weighting 40%
This assessment task supports CLOs 3 & 4

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

If you have a long-term medical condition and/or disability it may be possible to negotiate to vary aspects of the learning or assessment methods. You can contact the program coordinator or Equitable Learning Services if you would like to find out more.