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.
- ONPS2387 Principles of Toxicology (Course ID 042420) OR
- ONPS2032 Principles of Pharmacology (Course ID 028456)
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:
- Search, review and analyse the scientific literature in the field;
- Advance arguments and develop skills in public speaking and work effectively in a team environment;
- 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;
- Adapt knowledge to the application and approval processes of prescription and non-prescription pharmaceuticals and listed products;
- Identify key factors in health economics, pharmacovigilance and regulations regarding marketing and advertising of pharmaceuticals;
- 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.