Course Title: Ethics, Governance and Quality

Part A: Course Overview

Course Title: Ethics, Governance and Quality

Credit Points: 12.00


Course Coordinator: Durga Dharmadana

Course Coordinator Phone: +61 3 9925

Course Coordinator Email: durga.dharmadana@rmit.edu.au


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

This course will provide you with an overview of the business of supplying safe and effective medicines to the public. In this course you will explore the ethics of human clinical testing and the broader societal and ethical issues challenging the pharmaceutical industry. You will investigate the role of quality systems, and their importance in promoting medication safety. You will also be introduced to health economics and will examine how it influences healthcare.


Objectives/Learning Outcomes/Capability Development

This course contributes to the program learning outcomes for the following programs:

Bachelor of Pharmaceutical Science BP311

  • PLO1. Apply a breadth and depth of pharmaceutical science knowledge, concepts and evidence in various real world settings using a scientific approach.
  • PLO3. Demonstrate knowledge of the regulatory frameworks relevant to pharmaceutical sciences and exhibit safe and ethical conduct.

For more information on the program learning outcomes for your program, please see the program guide.


Upon successful completion of this course, you will be able to:

  1. Describe and discuss the key ethical considerations and issues associated with the development of new medications and therapeutics.
  2. Explain the principles of clinical research ethics, and the regulations that govern the conduct of clinical trials.
  3. Discuss the responsibilities of the pharmaceutical industry and government organizations in ensuring that medications are safe and effective.
  4. Examine the ethical, societal, and business challenges that influence drug development.
  5. Evaluate the interplay of factors that influence the cost of and access to therapeutics.


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: Essay
Weighting 25%
This assessment task supports CLOs  1, 3 & 4

Assessment Task 2: Presentation
Weighting 25%
This assessment task supports CLOs  4 & 5

Assessment Task 3: Report
Weighting 25%
This assessment task supports CLOs 1 & 3

Assessment Task 4: Ethics Assignment
Weighting 25%
This assessment task supports CLOs 1, 2, & 4

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.