Graduate Certificate in Regulatory Science

Course summary

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, biologicals 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 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.

The Graduate Certificate is a pathway for further studies or roles in the growing Biotechnology industry sector.

Career pathways include: regulatory or clinical affairs associates; research or development scientists; marketed-product support, quality assurance roles; biomedical, manufacturing and validation and process control engineers; post market surveillance and vigilance monitoring roles; distribution and legal representation of products, academia and government roles.

Your degree

This Graduate Certificate qualification produces career ready employable graduates. Students will acquire relevant critical skills and knowledge needed to become Regulatory affairs leaders ready for industry.

What you study

The Graduate Certificate has been designed by industry experts to provide real life case studies from authentic experiences.

Students will learn about the framework in which regulatory affairs is conducted by examination of the origins and current methodologies implemented by host regulatory authorities. It also examines the essential integration of quality management principles for effective execution of regulatory affairs.

Students will develop knowledge and skills in the requirements for regulatory oversight throughout the product placement, post market vigilance and monitoring phases of the Product Life Cycle.

Students will develop strategies to balance business objectives and compliance with regulatory requirements through the identification of risks and unknowns with marketing strategies.

Course information

Study area

Health & Medicine

Campus

Wollongong

Course Code

2119

ATAR (UAI)

-

Duration

1 year (2 sessions) part-time only

Delivery

Distance

Cricos

UAC Code

-

Admission, Key dates, and Fees

Academic Requirements

Tertiary qualification or equivalent experience in the area of regulatory affairs.

English Requirements

The following level of English is required to gain admission to this program:

English Test

Overall Score

Reading

Writing

Listening

Speaking

IELTS Academic

6.0

6.0

6.0

6.0

6.0

TOEFL (Internet-based)

79

18

18

18

18

UOW College: English for Tertiary Studies: Pass (weighted average mark of 50 overall and minimum 50 in Academic Reading and Writing)

Other qualifications may also be considered. Full details can be found on our English Language Requirements website.

Additional Criteria

Applicants may have experience in; quality assurance, medical products sales and marketing, medical products importation, government policy, medical products distribution, healthcare, government procurement, private health insurance.

Fees

2018 Information
Wollongong
Distance

Session Fee: $15,000
Full Course Fee: $15,000

Tuition fees are reviewed annually: fees payable are dependent on the year of commencement and are subject to increase during the period of study.

Overseas Health Cover:
Overseas Health Cover (OSHC) must be purchased for the proposed duration of the student visa. For information regarding the OSHC fees applicable, please refer to the international fees website.

Entry Requirements

Tertiary qualification or equivalent experience in the area of regulatory affairs.

Additional Criteria

Applicants may have experience in; quality assurance, medical products sales and marketing, medical products importation, government policy, medical products distribution, healthcare, government procurement, private health insurance.

Fees

2018 Domestic Fees / Commonwealth Supported Place
Wollongong
Distance

Session Fee: $12,672
Full Course Fee: $12,672

The above tuition fee is the amount payable for a full fee-paying place. Commonwealth Supported places are also available in some postgraduate coursework degrees in the Faculty of Science, Medicine & Health subject to quota availability.

For information regarding fees and assistance, including Commonwealth contribution amounts, please refer to the UOW Current Students website.

Tuition fees are dependent upon the actual year of commencement and are subject to change without notice.

Admission information

A range of admission options are available for students of all ages and academic backgrounds. The procedures governing admission are defined in UOW’s Admissions Procedures Policy, and the UOW College Admissions policy.

For any specific advice or questions regarding an application, please contact the Future Students Team.


Profile information

This information provides indicative enrolment and an explanation of the basis of admission of students in this course.


INDICATIVE ENROLMENT

This table is intended to show the breakdown of the student group for a course or group of related courses. Unfortunately there is currently no detailed information to provide, so please contact the UOW Future Students Team for more information.


ATAR PROFILE

This table relates to all students selected on the basis of ATAR alone or ATAR in combination with other factors. For more information on ‘bonus points’ and other ATAR-related adjustments commonly available to applicants, see ‘Points to UOW’.

ATAR PROFILE OF ATAR-BASED OFFERS IN 2016

ATAR

Selection Rank

Highest rank to receive an offer

-

-

75th percentile rank to receive an offer

-

-

Median rank to receive an offer

-

-

25th percentile rank to receive an offer

-

-

Lowest rank to receive an offer

-

-

L/N: Low numbers (less than 5 ATAR-based offers made)
N/P: Not published (less than 25 ATAR-based offers made)
Understanding ATAR profile data

ATAR refers to the unadjusted, raw ATAR profile for all students offered a place wholly or partly on the basis of ATAR.
Selection Rank figures represent the ATAR profile of the same student group but includes the impact of ATAR-related adjustments such as 'Points to UOW'.

STUDENT PROFILE

This table shows the breakdown of the applicant background of the student group at UOW for this course. It provides data on students that commenced undergraduate study and continued study beyond the census date at UOW in 2016.

APPLICANT BACKGROUND

2016 intake

2016 intake (%)

Higher education study

-

-

Vocational education & training study

-

-

Recent secondary education

Basis of admission

ATAR Only

-

-

ATAR plus additional criteria

-

-

Other criteria only (non-ATAR)

-

-

Work & life experience

-

-

International students

-

-

All students

-

-

L/N: Low numbers (number of students is less than 5)
N/A: Data not available for this item
N/P: Not published (hidden to prevent calculation of other numbers less than 5)
Understanding student profile data

Higher education study includes people who have studied a University course or completed a bridging or enabling course.
Vocational education and training (VET) study includes people who have undertaken VET study since leaving school.
ATAR only includes people admitted only on the basis of ATAR, regardless of whether this includes adjustment factors such as equity or bonus points.
ATAR plus additional criteria includes people who were admitted where both ATAR and additional criteria were considered (e.g. portfolio, audition, extra test,
early offer conditional on minimum ATAR).
Other criteria only (non-ATAR) includes people admitted on the basis of other criteria only and ATAR was not a factor (e.g. special consideration, audition alone,
schools recommendation scheme with no minimum ATAR requirement).
Work & life experience includes people admitted on the basis of previous achievement other than the above.
International student represents all other students.

MORE INFORMATION

For more information about UOW admission pathways, see UOW Admission Information.

2018 Autumn

Wollongong

Session Commences
26 February 2018

Applications Close
Key dates are:

  • Domestic Applicants: 31 January. Late applications will be accepted where places are available.
    Provided a complete application, including all required supporting documentation has been submitted, on-time applicants will be advised of their application outcome within two weeks of receipt.

  • International Applicants: One week prior to course commencement date.

Session Details
Orientation: 20 - 22 February 2018
Session: 26 February - 21 June 2018

2018 Spring

Wollongong

Session Commences

23 July 2018

Applications Close
29 June 2018. Late applications may be considered if places are available.

Session Details
Orientation: 16 July 2018
Session: 23 July - 15 November 2018

Course structure

(Current year structure - subject to change)

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. 

Course Handbook

(Current year structure - subject to change)

Why choose this course

There is a projected shortage of specialists in Australia qualified to enforce regulatory compliance and help businesses navigate the regulatory affairs framework using a quality management system approach. This course will prepare students for future employment opportunities in Regulatory Affairs and enhance their competitiveness across a range of career pathways, such as R & D, manufacturing, commercialisation, marketing & sales and distribution.

The course focuses on the evolving relationship between regulatory frameworks in the European Union and Australia, in response to forecast increased harmonisation between them. As such, graduates of the Graduate Certificate in Regulatory Science will be better prepared for future regulatory shifts within the industry, both internationally and domestically, and can maintain a competitive edge, especially where in-house regulatory knowledge can be of benefit to small to mid-size operations.