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Graduate Certificate in Regulatory Science | 2018
Testamur Title of Degree: | Graduate Certificate in Regulatory Science |
Abbreviation: | GCertRegSc |
UOW Course Code: | 2119 |
CRICOS Code: | N/A |
Total Credit Points: | 24 |
Duration: | 6 months full-time or part-time equivalent |
Home Faculty: | Faculty of Science, Medicine and Health |
Intake Session(s): | Autumn |
Delivery Mode: | Distance |
Delivery Campus / UAC Code: | Wollongong |
Overview
Regulatory Science is the process by which patient/customer safety is maintained by synthesising knowledge from various disciplines in a structured and legal framework. It was established from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, biological and medical devices.
A shift towards focusing on the “Product Life Cycle” is internationally recognised as the way forward in conducting regulatory affairs. It is an all-inclusive approach which deals with the science of product development and manufacturing, through to product placement, marketing, distribution and sales activities.
The product life cycle approach will broaden the employment scope for the regulatory affairs professional as technology and innovation in the health products area continues to evolve and become more complex. In order to safe guard the public into the future, Regulatory Science equally needs to expand to meet these demands to ensure that quality assurance is maintained at every stage of the supply chain.
The Graduate Certificate has been designed by industry experts that will provide real life case studies from their experience to create a course that provides the relevant critical skills and knowledge they need to become regulatory affairs leaders ready for industry.
The Graduate Certificate is suitable for those people who wish to enter the health science - Biotechnology industry or, healthcare workers wanting to broaden, advance and future proof their career by becoming advocates for maintaining the effectiveness of the product life cycle.
Entry Requirements and Credit Arrangements
Information on academic and English language requirements, as well as eligibility for credit for prior learning, is available from the Course Finder.
Course Learning Outcomes
Course Learning Outcomes are statements of learning achievement that are expressed in terms of what the learner is expected to know, understand and be able to do upon completion of a course. Students graduating from this course will be able to demonstrate:
| CLO | Description | ||||||
|---|---|---|---|---|---|---|---|
| 1 | Apply the essential knowledge to confidently enforce regulatory compliance to ensure patient safety in an increasingly complex regulatory environment. | ||||||
| 2 | Describe the function of a regulatory authority and the methodologies implemented to achieve patient safety. | ||||||
| 3 | Describe the Product Lifecycle regulatory framework and comprehensively explain the function of all economic operators in maintaining its purpose. | ||||||
| 4 | Articulate the underpinning principles of medical product quality assurance and how these maintain regulatory compliance and the Product Life Cycle. | ||||||
| 5 | Appreciate law and ethics in the therapeutics goods regulatory framework and for ensuring patient safety. | ||||||
| 6 | Competently establish a management process for economic operators involved in the interfacing, vigilance and monitoring stages of the Product Life Cycle to ensure they meet their regulatory responsibilities. | ||||||
| 7 | Review, evaluate and compile submissions for inclusion onto the Australian Register of Therapeutic Goods (ARTG). | ||||||
| 8 | Apply knowledge of regulatory compliance to manage the listing status of product(s) on the Australian Register of Therapeutic Goods (ARTG). | ||||||
| 9 | Review, analyse and synthesise information to identify solutions, responses and interpretations. | ||||||
| 10 | Exercise critical thinking in developing systems & processes to maintain the Product Lifecycle. | ||||||
| 11 | Communicate knowledge and findings within a team environment to a variety of audiences. | ||||||
Course Structure
To qualify for award of the degree, the Graduate Certificate in Regulatory Science, a candidate must successfully complete at least 24 credit points, as outlined below.
| Subject Code | Subject Name | Credit Points | Session(s) |
|---|---|---|---|
| SMAH901 | Fundamentals of Regulatory Science | 12 | Autumn |
| SMAH902 | Regulatory Science Interfacing, Vigilance and Monitoring | 12 | Autumn |
This program of study must be completed within a 5 year period from commencement of the course. Please note the 5 year period includes any leave of absences taken.
Other Information
For further information please email: smah-students@uow.edu.au