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  

You can pick the different modules you want to study. This flexibility is useful as you can choose ones you do not have experience with to broaden your knowledge”

Terms & conditions

Booking terms & conditions for the MSc Regulatory Affairs modules.


Module schedule

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

Modules 2025
UH Code Module Number Module Name Course Start Date Course End Date Module Leader
7FHH2011 2 Regulatory Strategy for a New Active Substance: Nonclinical Development 11/02/2025 13/02/2025 Lesley Reeve
7FHH2016 7 Regulatory Strategy for Established Active Substances  01/04/2025 03/04/2025 Orlaith Ryan
Eva Kopecna
7FHH2009 0 Overview of EU and UK Regulatory Affairs 15/04/2025 17/04/2025 Sacha Lynch
Grzegorz Kojro
7FHH2005 23 The EU Paediatrics Regulation 12/05/2025 14/05/2025 Evie Mongou
7FHH2023 13  Principles of Medical Device Regulatory Affairs 16/06/2025 18/06/2025 Richard Vincins
 7FHH2031 21 US Regulation of Medical Devices 23/07/2025 25/07/2025 Richard Vincins
 7FHH2006 24 The Regulatory Environment in the Middle East and North Africa  30/07/2025  01/08/2025  Farida Alayan
7FHH2024 14  Design, Development and Certification of Medical Devices 08/09/2025  10/09/2025  Jason Collins
Helen Erwood
 7FHH2022 22 Regulatory Requirements for Cell, Tissue and Gene Therapies  16/09/2025  18/09/2025  Daniel Rabbie
 7FHH2007 25 The Regulatory Environment in South/East Asia  07/10/2025  09/10/2025  Natasha Bankowski 
 7FHH2029 19 Regulation of In Vitro Diagnostic Medical Devices  20/10/2025 22/10/2025  Nancy Consterdine
Stuart Angell 
 7FHH2009 0  Overview of EU and UK Regulatory Affairs  04/11/2025 06/11/2025   Sacha Lynch
Grzegorz Kojro
 7FHH2019 10 Leadership and Strategic Management in Regulatory Affairs   10/11/2025 12/11/2025  Eva Kopecna
 7FHH2021 12 Data Management and Digitalisation in Regulatory Affairs   18/11/2025 20/11/2025  Peter Embley
 7FHH2030 20 Regulation of Electrical, Electronic and Software Devices   02/12/2025 04/12/2025  Richard Vincins

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