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Pharmaceutical Regulatory Affairs

What is the programme about?
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.

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.

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.

Duration

1 year full-time, 2 years part-time.

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
Joseph Collins
BA, HDipEd, STB, MEd, STL
E: LLL@itcarlow.ie

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

Course fee

CWS03 Master of Science in Pharmaceutical Regulatory Affairs CARLOW Full-time 9 90 €7,400*

CWL11 Master of Science in Pharmaceutical Regulatory Affairs CARLOW Part-time 9 90 €7,400*

CWS04 Postgraduate Diploma in Pharmaceutical Regulatory Affairs CARLOW Full-time 9 60 €5,500

CWL12 Postgraduate Diploma in Pharmaceutical Regulatory Affairs CARLOW Part-time 9 60 €5,500

*Fees for ITC Major Award graduates only – €5,500.

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