Qualifications

TOPRA provides a full range of postgraduate qualifications, offered in conjunction with the University of Hertfordshire


Take the first step by signing up to the MSc Regulatory Affairs programme, choosing the qualification that is most suitable for your current circumstances, work commitments and career aspirations. This part-time programme is fully flexible with the MSc taking up to six years to complete so you can take the course at your own pace and pay as you go.

Postgraduate Certificate Regulatory Affairs

    • Choose any four modules with assessments

    Postgraduate Diploma Regulatory Affairs (Medicines or Medical Devices)

    • Choose 8 modules, of which 6 must be from the pathway you are majoring in

    MSc Regulatory Affairs (Medicines) or MSc Regulatory Affairs (Medical Devices)   

    • Choose 8 modules as above and then include a final dissertation project, which can be aligned with your company’s needs.

    All modules are also run as standalone Masterclasses. You can sign up for your academic qualification immediately before your first module or after your first Masterclass.

    Please note: All applicants must have the right to work in the UK and you will be asked to provide evidence of this. Once accepted onto the course all students of the MSc must attend in person and not online. 

     CLICK HERE to find out more   

    Veronica Lipucci Di Paola Completing the full pathways MSc in Regulatory Affairs (Medicines) is a real satisfaction for professionals like me who love their job and work with passion in the pharmaceutical environment. TOPRA MSc is an extraordinary opportunity for professionals working in the sector to expand their regulatory knowledge not only at European level but also internationally. I would definitely recommend it.”  
    – Veronica Lipucci Di Paola, MSc

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    Study for a PhD

    Eligible postgraduates now have the opportunity to join TOPRA’s PhD Regulatory Affairs programme, also run with the University of Hertfordshire.

    Find out more


    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
     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
    7FHH2029 19
    Regulation of In vitro Diagnostic Medical Devices 20/10/2025   22/10/2025 Nancy Consterdine
    Stuart Angell
    7FHH2009 0 Overview of EU 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 Leah Heathman
    Alenka Drazumeric
    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
    Modules 2026
    7FHH2025
    15 Clinical Evaluation of Medical Devices
    20/01/2026
    22/01/2026
    Adrian Keene
    7FHH2006
    24 The Regulatory Environment in the Middle East and North Africa
     27/01/2026 29/01/2026 Natasha Bankowski
    7FHH2012
    3 Regulatory Requirements for a New Active Substance: Quality 
    10/02/2026
    12/02/2026
    Christian Maasch
    7FHH2007
    25
    The Regulatory Environment in South/East Asia
    24/02/2026
    26/02/2026
    Natasha Bankowski
    7FHH2028
    18 Drug-device Combinations and Other Technologies
    03/03/2026
    05/03/2026
    Phil Warner
    Natasha Bankowski
    7FHH2020
    11 The US Regulatory Environment 
    24/03/2026
    26/03/2026
    Nancy Smerkanich
    7FHH2009
    0 Overview of EU Regulatory Affairs
    14/04/2026
    16/04/2026
    Sacha Lynch
    Grzegorz Kojro
    7FHH2026 16 Post-Market Surveillance and Vigilance for Medical Devices   28/04/2026  30/04/2026  Adrian Keene
    Paul Risborough
     7FHH2017 8  Data for Abridged Applications and Specialised Products 19/05/2026  21/05/2026 Alenka Drazumeric Eva Kopecna 
    7FHH2023 13 Principles of Medical Device Regulatory Affairs  02/06/2026 04/06/2026 Richard Vincins 
    7FHH2014 5 Regulatory Control of Clinical Operations 07/07/2026  09/07/2026 Eva Kopecna 
    Pierre Omnes 
    7FHH2018 9 Registration of Biological, Biotechnology and Advanced Therapy Products  08/09/2026  10/09/2026 Rhydian Howells 
    7FHH2027 17  Regulatory Strategy in the Post-Market Phase 06/10/2026  08/10/2026 Jane Arnold Round 
    7FHH2011 2 Regulatory Strategy for a New Active Substance: Nonclinical Development  20/10/2026 22/10/2026 Lesley Reeve 
    7FHH2009 0 Overview of EU Regulatory Affairs  03/11/2026  05/11/2026  Sacha Lynch
    Grzegorz Kojro 
    7FHH2015 6  Regulatory Strategy: From Development to the Market Place 01/12/2026  03/12/2026  Vina Mistry 

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