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Institution / Institute of Technology Carlow Carlow Campus
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Pharmaceutical Regulatory Affairs

What is the programme about?
This Masters programme presents the regulatory affairs role and specifically targets the pharmaceutical regulatory industry. It also provides a detailed insight into EU legislation and regulation as well as an overview of US regulation. This programme is essential to meet the needs of the Irish pharmaceutical industry. All programme modules have been chosen and designed on the basis of leading industry advice and consultation and also meet the requirements of regulatory companies in sourcing regulatory and quality assurance personnel.

The programme enables existing regulatory affairs personnel in the pharmaceutical regulatory industry to understand all current diagnostic and medical device regulations and develop the necessary skills to work successfully in the dynamic world of regulatory affairs. The programme will also enable the graduate to develop a set of transferable skills to directly meet the requirements of a broad range of future employers including information technology, written and verbal communication skills, team working, independent research skills, data analysis and critical thinking. Teaching will involve traditional lectures supported and complemented by a managed learning environment incorporating elearning, discussion boards, and moderated online debates.

Entry requirements

A second-class honours degree in science, engineering, quality, pharmaceutical or regulatory affairs or cognate areas. Those failing to meet the classification requirement may be eligible for entry to the Postgraduate Diploma.

Candidates with significant experience in: pharmaceutical operations, quality engineering, device design, mid to senior management in industry, other professionals who wish to upskill in the regulatory affairs environment, regulatory affairs personnel themselves who want to upskill (as determined by the Institute’s recognition of prior learning policy), in addition to an honours primary degree in another discipline area may also be considered for entry.

Duration

2 years, part-time (2 evenings per week 7 - 10pm)

Careers or further progression

What will I be able to do when I finish this programme?
On completion of this programme, students should be able to:
• Devise and implement global strategies for drug, biologic, and device development and evaluation;
• Apply principles of basic and applied pharmaceutical sciences in drug and biologics discovery and development.

What follow-on study opportunities are available?
Opportunities for graduates from this programme include progression to Level 10 (PhD) programmes in related fields of study.

Potential employment opportunities
According to a report from the Forfás Expert Group on Future Skills Needs, Ireland is emerging as a leading location for biopharmaceuticals with a mix of start-ups, high growth SMEs and large multinationals located here.

Industry leaders including Pfizer, Eli Lilly, Sanofi, MSD (biologics based in Carlow) and Alkermes plc. have significant investment in Ireland which has facilitated rapid growth and
development of the industry.

These coupled with a strong generics industry (Wockhardt, Clonmel Healthcare both based in the South-East) provide prospective employment opportunities for graduates and key engagement partners for the programme.

At present, there are approximately 60 biopharmaceutical companies in Ireland employing an estimated 4,000 people. This
programme is designed to meet the growing demand for scientists to service the current and emerging biotechnology-based industries in Ireland in particular, the South-East, Mid-East
and Midlands. The current industrial perception is that Ireland’s future technology will predominantly be based upon biotechnology and IT orientated industries.

Further enquiries

Lifelong Learning Centre
Institute of Technology Carlow,
Kilkenny Road,
Carlow.
Tel: 059 9175280
Fax: 059 9175005
Email: lll@itcarlow.ie
Web: www.itcarlow.ie/lll

Subjects taught

Lifecycle Management, Vigilance,
Surveillance and Risk management
Pharmaceutical Technology Regulatory Affairs
Non Clinical and Clinical Evaluation of Pharmaceutical Technologies
Principles of Discovery of medicines and Development Planning
Research methods and Technical Report Writing
Special Populations and Biologicals and Advanced Therapies
Dissertation

Comment

Special Features of this programme
The primary objective of this Masters is to enable learners to expand their job responsibilities and opportunities in new areas after completing the programme. It will also enable learners to create an excellent network within the pharmaceutical industry, both by meeting other regulatory professionals during the course and by interacting with industry experts while completing their dissertation research. The programme is also designed to upskill professionals working in Regulatory Affairs who have already gained first-hand experience of handling regulatory issues.

Exit award
Students who successfully complete the relevant 60 credits of the programme will be eligible for the Postgraduate Diploma in Pharmaceutical Regulatory Affairs (Level 9) should they opt to leave the programme (Embedded Exit Award).

Fees
Students taking Level 6, 7 or 8 courses of 1 year duration or longer where course fees are €2,290 and who opt to pay full course fees by Saturday 2nd September 2017 will be eligible to benefit from the €300 discounted fee of €1,990.

For programmes where fees exceed €2,290 the appropriate fee payment regulation information is available from the faculty for Lifelong Learning.

(a) Course fees are expected to be paid in full at the commencement of the course. IT Carlow recognises that some students may have difficulties in paying the full amount in one transaction thus the Lifelong Learning Centre has created a number of fee payment by instalment options. All such applications will be treated in confidence. In general, fee payment by instalment applications will only be considered for fees in excess of €1,000.
Students who apply for and are granted a fee payment by installment plan should note that failure to meet the payment dates set down for their payment scheme, in particular key dates, may:
• be denied access to Blackboard
• be prevented from sitting examinations in December, May or August as applicable
• have all other assignment / exam results withheld until payments are made
• assignments will not be accepted nor will a late submission for an assignment be accepted after late payments are made
• pay an additional surcharge.

(b) Students in receipt of employer sponsorship etc. will be required to submit a letter of confirmation of commitment to pay from their employer of funding body. They must also include a Purchase Order Number for invoice purposes. Where fees have not been paid by the ‘sponsor’ within thirty days after issue of the invoice, it is the responsibility of the student to then pay the fee and claim back fees from their sponsor.

(c) Repeat students will be required to pay relevant examination fee when applying to sit the repeat.

(d) The Faculty for Lifelong Learning has a strict policy in relation to Refund of Course Fees and a fees refund or a percentage of same will only be given in the following circumstances:
• A full refund will be given if requested in writing before the commencement of the course.
• Where a student leaves within two weeks of the start of a short course (10-13 weeks), 70% refund of the course fee will apply. Outside this two week period there will be no refund of fees.
• For long courses i.e. those of one-year duration or longer, a percentage of fees refund will be given over the first nine weeks of the course as per table 1. Thereafter there will be no refund of fees.
• The refund calculation is based on the full fee for the course not the amount that a student may have paid under a fees payment installment agreement.
• The fees refund calculation is based on the date that the student formally applies in writing to withdraw from the course.
• All courses will run subject to sufficient numbers. Where a course has to be cancelled those students who have registered and paid will be refunded in full.
• Receipts must be retained and produced when requesting a refund of course fees which must
be applied for on the official refund form.

Application date

Closing Date for Applications

All Postgraduate Applications – 12 noon 14th August 2017

All other applications – 12 noon Friday 25th August 2017

Course fee

€7,400

Enrolment and start dates

Registration / Orientation Saturday 2nd September 2017

Courses Commence
Monday 11th September 2017

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