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Pharmaceutical Regulatory Affairs

This Masters course 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 course meets the needs of the Irish pharmaceutical industry, with course modules chosen and designed on the basis of leading industry advice and consultation. It also meets the requirements of regulatory companies in sourcing regulatory and quality assurance personnel.

The course 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 course 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.

Exit Award - Yes.

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

1 Year Full-time, 2 Years Part-time.

Careers or further progression

Study & Career Opportunities
Opportunities for graduates from this programme include progression to Level 10 (PhD) programmes in related fields of study.

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

Dr Denise Noonan BSc, MSc, PhD
Programme Director
E: LLL@itcarlow.ie

or

Joseph Collins BA, HDipEd, STB, MEd, STL
Head of Faculty, Lifelong Learning
P: 059 917 5280
E: joseph.collins@itcarlow.ie

International (Non-EU) applicants may contact:
E: international@itcarlow.ie
P: 00353-59-9175205

Subjects taught

What subjects will I study?
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

Postgraduate Opportunities - Institute of Technology Carlow. Institute of Technology Carlow has a range of high-quality courses that offer suitably qualified primary degree holders (NFQ Level 8) exciting opportunities to progress to higher awards (Masters and Doctoral degrees). These opportunities are by research and thesis or taught courses, with many available on a full-time or part-time basis across our three campuses in Carlow, Wicklow and Wexford.

Higher Degrees by research are normally obtained by undertaking a research project, guided by an experienced supervisor. The average duration of a research Masters degree (NFQ Level 9) is 2 years full-time study. A PhD (NFQ Level 10) should take from 3 to 4 years (full-time) to complete.

Taught courses are available at three levels: Higher Diploma (NFQ Level 8); Postgraduate Diploma - NFQ Level 9 (60 credits); and Masters - NFQ Level 9 (90 credits). Individual full-time postgraduate courses are described in the forthcoming sections. Details of part-time taught courses are available in the Lifelong Learning prospectus.

Research Masters and Doctoral Degrees
Institute of Technology Carlow offers postgraduate research supervision for both Research Masters and Doctoral Degree candidates (NFQ Levels 9 and 10). Research supervision is closely tied to the priorities and expertise of staff attached to specialist research centres at Institute of Technology Carlow. Research, Development and Innovation (RDI) is an integral part of Institute of Technology Carlow's activities and a vital aspect of its interaction with industry and other research centres, both nationally and internationally.

Application date

How to apply
1. Research & choose your course from our wide range of postgraduate offerings on our website or in our prospectus.

2. Check out all of the relevant entry requirements, course code and closing dates, taking time to read IT Carlows FAQs and application instructions on the Admissions section of the website.

3. Get started on your postgraduate journey at IT Carlow!

For admissions queries from Irish or European applicants, please email: graduatestudies@itcarlow.ie.

All Non-EU international applicants may refer to the International section of the website for further details or email: international@itcarlow.ie.

Course fee

This course is not eligible for Free Fees. Programme Fees 2017/18 €7,400. Fees under review for 2018/19.

Enrolment and start dates

Postgraduate application procedure
Postgraduate applicants should refer to the Study/Postgraduate section of the website for more information: www.itcarlow.ie/study/postgraduate-rd.

Remember to mention gradireland when contacting institutions!