Modules | TOPRA MSc Regulatory Affairs programme

The MSc programme comprises 26 modules, 8 of which must be completed, in addition to the dissertation, to earn the master’s degree. The programme operates on a roll-on, roll-off basis, allowing students to join at the point of registering for their first module, and modules can be taken in any order. The programme is offered part-time (1–6 years).

Below is the list of modules for each pathway. Visit our Masterclasses page to see which modules are currently open for registration.

Medicines pathway

Module 0 - Overview of EU and UK Regulatory Affairs

Module 1 - Strategic Planning in Regulatory Affairs   

Module 2 - Regulatory Strategy for a New Active Substance: Nonclinical Development   

Module 3 - Regulatory Requirements for a New Active Substance: Quality  

Module 4 - Regulatory Strategy for a New Active Substance: Global Clinical Development  

Module 5 - Regulatory Control of Clinical Operations  

Module 6 - Regulatory Strategy: From Development to the Market Place  

Module 7 - Regulatory Strategy for Established Active Substances  

Module 8 - Data for Abridged Applications and Specialised Products  

Module 9 - Registering Biological Biotechnology and Advanced Therapy Products

Module 10 - Leadership and Strategic Management in Regulatory Affairs

Module 11 - The Regulatory Environment in the USA  

Module 12 - Data Management and Digitalisation in Regulatory Affairs  

Module 22 - Regulatory Requirements for Cell, Tissue & Gene Therapies  

Module 23 - The EU Paediatrics Regulation

Module 24 - The Regulatory Environment in the Middle East and North Africa

Module 25 - The Regulatory Environment in South/East Asia

 
Medical Devices pathway

Module 10 - Leadership and Strategic Management in Regulatory Affairs  

Module 12 - Data Management and Digitalisation in Regulatory Affairs  

Module 13 - Principles of Medical Device Regulatory Affairs  

Module 14 - Design, Development and Certification of Medical Devices  

Module 15 - Clinical Evaluation of Medical Devices  

Module 16 - Post-Market Surveillance and Vigilance for Medical Devices   

Module 17 - Regulatory Strategy in the Post-Market Phase  

Module 18 - Drug-device Combinations and Other Technologies  

Module 19 - Regulation of In Vitro Diagnostic Medical Devices   

Module 20 - Regulation of Electrical, Electronic and Software Devices   

Module 21 - Regulation of Medical Devices in the USA

Average Delivery Hours:
Each module will detail the individual agenda and timings, but on average: 

Module schedule

The following table outlines the scheduling for all MSc modules taking place in the 2026/2027 Academic Year.

*This schedule is subject to minor changes.