Overview
Status: Active
National Framework Of Qualifications (NFQ) Level: 9
NFQ Award Class: Major Award
Duration Full Time: 1 Academic Year(s)
Total Credits: 60
Connected Curriculum: - Employability
- Global Reach
- Inter-and Transdisciplinary
- Research Based Teaching
- Sustainability
Sustainable Development Goals (SDGs): - Good Health and Well-being
- Decent Work and Economic Growth
- Industry, Innovation, and Infrastructure
- Responsible Consumption and Production
Graduate Attributes: - Creator, evaluator and communicator of knowledge
- Digitally Fluent
- Independent and creative thinker
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 |
| PF6044 | Digital Transformation in the (Bio)pharma Industry | 5 |
| PF6124 | Introduction to Clinical Trial Design and Analysis | 10 |
| 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:
- Assess pharmaceutically relevant datasets using appropriate statistical and machine learning methodologies.
- Develop manufacturing processes which apply quality-by-design principles for a range of medicinal products including small molecules, biopharmaceuticals and ATMPs.
- Critically evaluate the regulation of medicinal products and identify opportunities to accelerate the integration of emerging science and technology in medicines’ development.
- Appraise the quality, safety and efficacy of a medicine based on the clinical trial outcomes and real-world data.
