About Master Of Science In Pharmaceutical Regulatory Affairs in Institute of Technology Carlow

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.

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 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

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 course. 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.

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 course.

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.

Academic qualification equivalents

• Applicants should have an honours degree in a related subject.

English language requirements (one of the below):

• IELTS: 6.0 IELTS(minimum of 5.5 IELTS in each component)
• TOEFL: iBT 90 , CBT 232 , PBT 575
• PTE: 58 - 64