Course Title: Drug Regulations
Part A: Course Overview
Course Title: Drug Regulations
Credit Points: 12.00
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
Course Coordinator: Dr Celine Valery
Course Coordinator Phone: +61 3 9925 7482
Course Coordinator Email: firstname.lastname@example.org
Course Coordinator Location: Bundoora West Campus - 201.09.06
Course Coordinator Availability: By Appointment
Pre-requisite Courses and Assumed Knowledge and Capabilities
You are expected to have a sound background knowledge in the discipline area of pharmacology and clinical trial design.
ONPS 2443 (Principles of Pharmacology 2) and ONPS2304 (Clinical trial design and management) are required prior to study. Students who have not successfully completed the prerequisites must withdraw, or will be withdrawn if they incorrectly enrol in this course.
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 (PLO2)
- Communication and teamwork (PLO3)
- Investigation and analysis (PLO4)
On completion of this course you should 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
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 self-directed learning, tutorials, group work 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 required to manage information delivered flexibly through course manuals as well as face-to-face teaching. 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 tutorials.
Independent study: two (2) hours per week for one semester, including analysing articles, writing essays, working on project, revising lectures and tutorials.
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.
☐ All hurdle requirements for this course are indicated clearly in the assessment regime that follows, against the relevant assessment task(s) and all have been approved by the College Deputy Pro Vice-Chancellor (Leaning & Teaching).
Assessment Task 1: Weekly in-class tests
This assessment task supports CLOs 3,4,5
Assessment Task 2: Tutorial project with guest lecturer from industry
This assessment task supports CLOs 1,2,3,4,6
Assessment Task 3: Essay on contemporary topic related to drug regulations
This assessment supports CLOs 1,6
Assessment Task 4: Mid-semester exam
This assessment supports CLOs 3,4
Assessment Task 5: Project (team work)
This assessment supports CLOs 1,2,3,4,5
Assessment Task 6: Final exam
This assessment supports CLOs 3,4,5,6