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 Pharmaceutical 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