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, Sem 2 2024, Sem 1 2025 |
Course Coordinator: Dr Roman Falls
Course Coordinator Phone: +61 3 9925
Course Coordinator Email: roman.falls@rmit.edu.au
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 program learning outcomes for the following program(s):
PLO1 Apply a breadth and depth of pharmaceutical science knowledge, concepts and evidence in various real-world settings using a scientific approach
PLO2 Apply systematic thinking and a range of high-level analytical skills using a blend of digital and traditional tools and technologies to solve complex scientific and medical problems related to pharmaceutical science
PLO3 Demonstrate knowledge of the regulatory frameworks relevant to pharmaceutical sciences and exhibit safe and ethical conduct
PLO4 Communicate clearly and effectively with diverse audiences utilising contemporary and traditional formats on topics related to pharmaceutical science employing integrity, inclusivity, and culturally safe practices
PLO5 Demonstrate critical reflection skills, responsibility and accountability for own learning and professional practice as part of a multidisciplinary team.
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. Differentiate key factors in the regulation of therapeutic goods in Australia, including registration and manufacture of prescription & non-prescription pharmaceuticals and medical devices.
2. Contrast the application and approval processes of listed and registered medicines.
3. Explain key factors in health economics, pharmacovigilance and regulations regarding marketing and advertising of therapeutic goods.
4. Evaluate Australian and Global approaches to the regulation of therapeutic goods and the pharmaceutical industry.
5. Communicate on topics related to pharmaceutical sciences in a clear, effective, and professional manner
6. Demonstrate responsibility and accountability for own learning and professional practice as part of a multidisciplinary team
Overview of Learning Activities
You will be actively engaged in a range of learning activities such as lectorials, workshops, project work, class discussion, and individual and group activities. Delivery may be face-to-face, online or a mix of both.
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, teamwork 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.
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: Regulatory Process Assignment
Weighting 15%
This assessment task supports CLOs 1, 2, 3, 4 & 5
Assessment Task 2: Group Project Reports & Presentation (teamwork)
Weighting 40%
This assessment task supports CLOs 1, 2, 3, 4, 5 & 6
Three group project reports at 10% each
One presentation at 10% each
Assessment Task 3: End-of-semester invigilated test
Weighting 35%
This assessment task supports CLOs 1, 2, 3 & 4
Assessment Task 4: Critical Reflective Essay
Weighting 10%
This assessment task supports CLO 5 & 6
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.