This two-year distance learning course is aimed at graduates who currently work within the pharmaceutical industry who wish to fulfil the EU educational requirements for Qualified Person (QP) status. Graduates who complete this course and have the relevant work experience are eligible to apply to the Health Products Regulatory Authority (HPRA) or EU regulatory authority to register as a QP.

The course is not limited to aspiring QPs. It is designed to broaden your professional development and provide up-to-date assessments of the latest trends in the areas of pharmaceutical/ biopharmaceutical development, manufacturing and quality. The individual modules provide knowledge and experience of benefit to all technical, quality, regulatory and managerial staff in the pharmaceutical industry.

Course Requirements (Pathway 1)

In Part I, you will take taught modules to the value of 60 credits, run over a minimum of 18 months. The taught modules incorporate a combination of self-instructional printed materials (i.e. printed module workbooks), teleconferences, web-based seminars and online assessments. Students must also attend the two three-day workshops on campus each year, involving lectures, practical sessions, tutorials and industrial site visits.

In Part II, you complete a research project module to the value of 30 credits. If you want to pursue the course, you must be able to carry out your research project in your place of employment.

Modules (90 credits):

Part I

• PF6200 Pharmaceutical Chemistry (10 credits)
• PF6201 Pharmaceutical Dosage Form Design (5 credits)
• PT6401 Pharmacology (5 credits)
• PF6202 Pharmaceutical Manufacturing - API to Finished Product (5 credits)
• PF6203 Pharmaceutical Microbiology and Sterile Manufacturing (5 credits)
• PF6204 Biopharmaceutical Development of Investigational Medicinal Products (5 credits)
• PF6205 Pharmaceutical Biotechnology (5 credits)
• PF6206 Pharmaceutical Statistics and Process Control (5 credits)
• PF6207 Pharmaceutical Plant and Process: From Design through Validation (5 credits)
• PF6208 Quality Management Systems and Regulatory Affairs (5 credits)
• PF6209 Role and Professional Duties of the Qualified Person (5 credits)

Part II

• PF6210 Research Project - Pharmaceutical Technology and Quality Systems (30 credits)
• The research project will be centred in an industrial pharmaceutical setting. Consideration will be given to your chosen project area but all project titles must be approved in advance by the course committee and supervised by a member of academic staff at UCC.

Why Choose This Course

The MSc in Pharmaceutical Technology and Quality systems has been approved by the HPRA in meeting the educational requirements for QP status as stated in directive 2001/83/EC. Students who have completed this course and have the relevant work experience are eligible to apply to an EU regulatory authority to register as a QP.

Skills and Careers Information

Although the course meets the educational requirements for registering as a QP, it is not only aspiring QPs who complete the course. Many of our graduates use the skills obtained in the course to develop their careers within other areas of the pharmaceutical industry.

Students from the EU can use this qualification to apply to your regulatory authority to register as a QP. Last year, a number of students from Malta graduated from this course and registered as QPs in Malta.