Overview
The Postgraduate Diploma in Pharmaceutical Regulatory Sciences is a full time programme delivered in a blended format, running over a minimum of 9 months from the date of first registration for the programme.
Students must satisfactorily complete taught modules to the value of 60 credits.
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 |
| Total Credits | 60 |
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 Postgraduate Diploma 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.
