Overview
The MSc in Pharmaceutical Regulatory Sciences is a full-time programme delivered in a blended format, running over a minimum of 12 months from the date of first registration for the programme.
Graduates of the Postgraduate Diploma in Pharmaceutical Regulatory Sciences who obtain a place on the MSc programme may apply for exemptions for modules already completed.
Exit Award
Postgraduate Diploma in Pharmaceutical Regulatory Sciences (NFQ Level 9, Major Award)
Upon successful completion of taught modules to the value of 60 credits, registered MSc in Pharmaceutical Regulatory Sciences students may opt not to proceed with the programme and exit with a Postgraduate Diploma in Pharmaceutical Regulatory Sciences.
Programme Requirements
For information about modules, module choice, options and credit weightings, please go to Programme Requirements.
Programme Requirements
Module List
| Code |
Title |
Credits |
| |
| EH6136 | Pharmacoepidemiology | 5 |
| EH6137 | Pharmaceutical Data Management and Pharmacovigilance | 5 |
| PF6026 | Pharmaceutical Technology and Unit Operations with Regulatory Insights | 5 |
| PF6027 | Pharmaceutical GxP and Regulatory Science | 5 |
| PF6028 | Process Control and Validation for Pharmaceutical Processes | 5 |
| PF6029 | Biotechnology-derived and Advanced Therapy Medicinal Products (ATMPs) | 5 |
| PF6032 | Bioprocessing Unit Operations | 5 |
| PF6038 | Skills Development in Pharmaceutical Regulatory Sciences | 10 |
| ST6024 | Introduction to Probability and Statistics | 5 |
| ST6025 | Statistical Modelling | 5 |
| ST6026 | Basics of Machine Learning | 5 |
| PF6031 | Dissertation in Pharmaceutical Regulatory Sciences | 30 |
| Total Credits | 90 |
Examinations
Full details and regulations governing Examinations for each programme will be contained in the Marks and Standards Book and for each module in the Book of Modules.
Programme Learning Outcomes
Programme Learning Outcomes for MSc in Pharmaceutical Regulatory Sciences (NFQ Level 9, Major Award)
On successful completion of this programme, students should be able to:
1
1-3
Assess pharmaceutically relevant datasets using appropriate statistical and machine learning methodologies.
1-4
2
Develop manufacturing processes which apply quality-by-design principles for a range of medicinal products including small molecules, biopharmaceuticals and ATMPs.
1-5
3
Critically evaluate the regulation of medicinal products and identify opportunities to accelerate the integration of emerging science and technology in medicines’ development.
1-6
4
Appraise the quality, safety and efficacy of a medicine based on the clinical trial outcomes and real-world data.
1-7
5
Integrate interdisciplinary knowledge to execute a project relating to the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of a drug product.
