Program Overview

Master of Science in Pharmaceutical Quality Assurance and Regulation

Overview

The MSc in Pharmaceutical QA and Regulation provides specific education at postgraduate level in ‘Quality Assurance’ and Pharmaceutical Regulatory requirements, to scientists and other professionals who operate in the ‘Quality Environment’ of the bio/pharmaceutical industry.

Course Details

• TU Code: TU288
• NFQ Level: Level 9
• Award Type: Major
• Award: Master of Science
• ECTS Credits: 90
• Duration: 2.5 years
• Course Type: Postgraduate
• Mode of Study: Part Time
• Method of Delivery: Online
• Commencement Date: September 2025
• Location: Grangegorman
• Fees: €4,400 Per Year, €8,800 Total Fee

What is Pharmaceutical Quality Assurance & Regulation?

The course is tailored to those who wish to work in the pharmaceutical sector, providing an industry-relevant, broad-based curriculum which focusses on the Quality and Regulatory Framework for the bio/pharmaceutical industry.

Minimum Entry Requirements

• Honours bachelor degree in science or related discipline at 2.2 grade or higher or equivalent qualification.
• Applicants for the part-time course should be employed in a relevant industrial sector.
• Selection of suitable candidates will be by interview.

Course Content

The course is divided into two stages – stage 1 and stage 2.

Stage 1

• The taught part of the programme (nine modules), is delivered to students on a part-time basis over two years.
• Students undertake the nine modules over 4 semesters.
• All modules are assessed by assignment.

Stage 2

• On successful completion of the nine modules, students undertake a 6 months industrial based dissertation while working in their place of work.

Modules

• Year One
  • Advanced Therapeutics and their Regulation [Mandatory]
  • Pharmaceutical Technologies (Process, Facility, Equipment & Utilities) [Mandatory]
• Year Two
  • Pharmaceutical Manufacturing and Management [Mandatory]
  • Innovative Medicines and their regulation [Mandatory]
  • Quality Risk Management [Mandatory]
• Year Three
  • Dissertation [Mandatory]

Module Listing

• Semester 1
  • Advanced Therapeutics and their Regulation [Mandatory]
  • Pharmaceutical Technologies (Process, Facility, Equipment & Utilities) [Mandatory]
• Semester 2
  • Pharmaceutical Manufacturing and Management [Mandatory]
  • Innovative Medicines and their regulation [Mandatory]
  • Quality Risk Management [Mandatory]

Schedule

• The course consists of 100% virtual online delivery.
• Students will normally have an average of seven contact hours per week, comprising lectures, case studies and discussion sessions.
• The modules are normally delivered on 2 evenings and a Saturday morning each week over the course of the semesters.

Research Areas

• Pharmaceutical Microbiology and Aseptic Manufacture (Drug Product)
• Pharmaceutical Quality Assurance & Research Methods – 10 ECTS
• Pharmaceutical Regulation, Validation and Statistics – 10 ECTS
• Biopharmaceutical Manufacture (Drug Substance)
• Process Technologies (Process, Facilities, Equipment & Utilities) 10 ECTS
• Quality Risk Management
• Pharmaceutical Manufacturing & Management
• Advanced Therapeutics & their Regulation
• Innovative Medicines & their Regulation

Note

• There are three 10 ECTS modules as indicated above, the remaining six modules are 5 ECTS.
• Due to the considerable competition for our postgraduate courses satisfying the minimum entry requirement is not a guarantee of a place.
• Depending on the course of study applications will be assessed based on their academic grades and may also take into account their work/life experience.
• Applicants will also be required to attend an interview for specific courses.
• Interviews will be virtual , applicants do not have to attend in person.