Master of Science in Pharmaceutical Regulatory Affairs
Master of Science in Pharmaceutical Regulatory Affairs
NFQ Level 9
Details available on the Admissions-Postgraduate pages
1 Year Full-time / 2 Years Part-time
Postgraduate Diploma in Science in Pharmaceutical Regulatory Affairs (Level 9 - 60 credits)
- Entry Requirements
- Further Study & Careers
- PAC Codes & Fees
- How to apply
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.
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?
- Life-cycle 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
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.
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.
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.
Programme Codes & Fees
|Programme Code||Programme Title||Campus Location||Schedule||Fees||Closing date for applications|
|CWS03||Master of Science in Pharmaceutical Regulatory Affairs||Carlow||Full-time||€7,400*||Details available on the Admissions-Postgraduate pages|
|CWL11||Master of Science in Pharmaceutical Regulatory Affairs||Carlow||Part-time||€7,400*|
|CWS04||Postgraduate Diploma in Science in Pharmaceutical Regulatory Affairs||Carlow||Full-time||€5,500|
|CWL12||Postgraduate Diploma in Science in Pharmaceutical Regulatory Affairs||Carlow||Part-time||€5,500|
|* Fees for ITC major award graduates only €5,500|
How to apply
- Research & choose your programme from our wide range of postgraduate offerings on our website or in our prospectus.
- Check all of the relevant programme information including entry requirements, programme code and closing dates, taking time to read the Application Instructions.
- Get started on your postgraduate journey at IT Carlow!
For admissions queries from Irish or European applicants, please email: email@example.com.
All Non-EU international applicants should refer to the International section of the website or email: firstname.lastname@example.org.