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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.

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).

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.

ELIGIBILITY
• Jobseekers
• Returners
• Those in employment

Duration

1 year part-time (2 evenings per week & some Saturdays)

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

What is Springboard+?
Springboard+ is a government initiative offering Higher Education courses to eligible individuals - for FREE - at Certificate, Degree, Higher Diploma and Masters Levels which lead to qualifications in areas where there are employment opportunities in the economy.

Springboard provides free upskilling in higher education in areas of identified skills need. The initiative's primary target group has been unemployed people with a previous history of employment. In 2014, Springboard incorporated ICT Skills Conversion courses (i.e. Springboard+), some of which are open to applicants regardless of their employment status.

Who is Eligible? All courses are open to eligible applicants irrespective of their employment status.

There are three categories of applicant:
1. Those in receipt of an eligible Department of Employment Affairs & Social Protection (DEASP) payment and the previously self-employed;

2. Returners seeking to re-enter the workforce;

3. People in employment seeking to reskill or upskill.

People participating in the Community Employment Scheme; the Rural Social Scheme; Tús; JobBridge or in receipt of the Back to Work Enterprise Allowance or the Short Term Enterprise Allowance may apply for Springboard and, with the approval of a Department of Social Protection Case Officer, take up a Springboard course.

To participate in a NFQ Level 9 (Post Graduate) course, a period of at least one-year must have elapsed since completing a full time undergraduate degree course leading to a major award at Level 8 on the NFQ.

Proof of Eligibility
Applicants will also be required to provide evidence that they meet the eligibility criteria for the Springboard Initiative.

• Those in receipt of a qualifying Department of Social Protection will be required to provide evidence of this payment.

• Returners will be required to provide a letter/statement signed by a Commissioner for Oaths confirming their status as a homemaker.

• Those in employment will be required to provide a copy of their most recent P60 or a letter from their current employer to confirm their employment.

Further information on eligibility is available on www.springboardcourses.ie

Application date

How To Apply for a Springboard Course
Springboard applications are made online at www.springboardcourses.ie

To make an application you will need to complete a short registration process and then fill out an online application form. It is important that you fill out the online application form as fully and completely as you can in order to make a valid application and in order to best make your case for a place.

What happens after that? Following the closing date Institute of Technology Carlow will process the applications. Applicants may be shortlisted on the basis of the evidence in the application and any further supporting documents supplied. It is therefore important that you complete the online application form accurately and fully and supply scanned copies of supporting documentation as below.

Shortlisted candidates may be called for a brief interview. Successful candidates will get an offer of a place by e-mail and courses will begin in September. Further detailed information will be supplied during the application/offer process.

Supporting Documentation
Entry requirements for courses are set out in the course description on www.springboardcourses.ie - these entry requirements will require you to supply evidence of your previous education and qualifications. It is important that you support your application with electronic/scanned copies of supporting documents – where required - such as:

• An up-to-date CV
• Scanned copies of all of your official educational qualification parchments
• Scanned copies of all of your official educational transcripts clearing showing the results you achieved in each subject/module.
• Scanned copies of all of your employment references

Queries can be directed to springboard@itcarlow.ie

Course fee

For employed participants on courses at NFQ Level 7, 8 or 9, 90% of the course fee is paid by the HEA. Participants will be liable for the remaining 10% fee. Fees will be due once a place has been accepted. Level 6 courses are free to all eligible participants.

Enrolment and start dates

Registration / Orientation
Saturday 1st September 2018.

Courses Commence
Monday 10th September 2018.

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