Modules | TOPRA MSc Regulatory Affairs programme

For more information on each module click through to the content covered, learning outcomes and when it will run.* Medicines and Medical Device pathways are colour-coded (in blue and red respectively) for ease of identification. For an MSc, you may choose up to two courses from the alternative pathway to broaden your qualification and knowledge.

Medicines pathway

Module 0 - Overview of EU 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 - Registration of Biological, Biotechnology and Advanced Therapy Products   

Module 10 - Leadership and Strategic Management in Regulatory Affairs  

Module 11 - The US Regulatory Environment  

Module 12 - Data Management and Digitalisation in Regulatory Affairs  

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

 
Medical Devices pathway

Module 10 - Leadership and Strategic Management 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 - US Regulation of Medical Devices  

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

Module schedule

The following table outlines the scheduling for all MSc modules taking place in 2025.

*This schedule is subject to minor changes.
Visit our Masterclasses page to see which modules are currently open for registration.