NFQ Level 9
Classroom - Evening
Augusta AdekoyaEmail Phone
Institute of Technology Carlow
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.
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.
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.
This course will develop knowledge of the design, development, analysis and production of medicines, the drug industry and regulatory affairs. It is particularly suitable for those who are keen to enter employment in areas such as pharmaceutical marketing, formulation, sales, production, public relations, regulatory affairs, process development, medical statistics and clinical trial organisations.
Students will learn about a broad range of formulations and pharmaceutical technologies through the use of examples and case studies along with the underpinning science. They will be given hands-on experience in a number of preformulation and formulation technologies. Clinical trials and other aspects of regulatory affairs, including those covering biotechnological products will be covered in an integrated manner. Employability has been embedded into the course and the varied assessment strategies reflect this. Our Teaching and Learning Centre and the use of formative (practice) assessments are intended to give students the opportunity to develop communication, computing and other key skills.
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.
1 YEAR — PART-TIME
(2 evenings per week &
Institute of Technology Carlow
Apply online at www.springboardcourses.ie
To complete your application process you must email Springboard@itcarlow.ie with the following
(1) A scanned copy of your EU Passport, or a scanned copy of your non-EU Passport with a copy of your Stamp 4 visa. You are not required to provide a copy of your Public Services Card to verify ID.
(2) A copy of your Curriculum Vitae.
(3) A copy of your Level 7 Degree/ Major Award or highest other qualification. Translated if not in English
(4) A scanned copy of a recent payslip if employed showing your PPSN, or a scanned copy of a recent payment slip if in receipt of Jobseekers Allowance/ benefit, or a copy of a recent Bank Statement showing receipt of a different, eligible, Department of Employment Affairs & Social Protection, or a letter from your Accountant confirming that are Self-employed, or an Affidavit signed by you and the appropriate third-party confirming that you are a Homemaker. When sending jpgs they must be attachments to your email, -not jpgs within emails.