MSc Regulatory Affairs (Medicines)

The new TOPRA MSc will begin in February 2018. To join the programme, please contact Kay, our postgraduate administrator.

About the MSc

TOPRA is pleased to announce that our new MSc has been validated by the University of Hertfordshire and will begin in February 2018.

Prior to this we will be running some medical device modules as master classes with short course accreditation. On successful completion of the coursework you will gain 15 UK (7.5 ECTS) credits which can then be transferred to the new MSc course once this begins if you are accepted to the MSc and pass the coursework.

The two new MSc titles are MSc Regulatory affairs (Medicines) and MSc Regulatory affairs (Medical Devices). Students may be eligible for a distinction or commendation depending on their final results on completion of their studies after a maximum time period of six years.

Upcoming modules

Begin DateTitleDescription
11/13/2017Autumn Introductory Course 2017An introduction to Pharmaceutical Regulatory Affairs and MSc Regulatory Affairs Module 0 - 7FHH1097 of the MSc Regulatory AffairsIC217
2/14/2018Regulation of In Vitro Diagnostic Medical DevicesModule 19 of the MSc (Medical Devices) and Masterclass. The course will cover both the current regulatory environment and the new medical device regulation in the EU and other jurisdictions such as the US, Japan, China and Brazil.MC192018
4/11/2018The US Regulatory EnvironmentModule 11 of the MSc (Medicines) and Masterclass: The purpose of this module is to provide you with an understanding of the regulatory environment in the USA in order to place these global influences in perspective. As the largest single country market for pharmaceutical products, the regulatory requirements of the US FDA has a major influence on the design of pharmaceutical development programmes both within the USA and globally. This module offers an understanding of the US regulatory environment in order to place these global influences in perspective.MSCM112018
11/27/2017Regulatory Strategy for a New Active Substance: GCDModule 4 of the MSc: This will enable you to develop effective regulatory leadership within your organisation throughout the clinical development and the registration of a new medicine.MSCM42017
1/31/2018Regulatory Control of Clinical OperationsModule 5 of the MSc (Medicines) and Masterclass: This module will provide you an understanding of the practical and regulatory aspects of global clinical research, in order to offer effective advice on the regulatory issues likely to arise during clinical programmes.MSCM52018

Experiences of the MSc

Some of our graduates and module leaders talk about their experiences of the Regulatory Affairs MSc.

Entry requirements

To be admitted to the MSc, candidates will normally need to have 2 years’ experience in regulatory affairs and hold a science degree or equivalent. Read more about TOPRA MSc entry requirements.


TOPRA MSc fees guide
(Microsoft Word Document)

Frequently asked questions

If you have a question about the TOPRA MSc, you could find the answer on our FAQ page.

Terms and conditions

Booking conditions for the MSc Regulatory Affairs modules.


Download an application form
(Microsoft Word Document)
Programme specification
(Adobe PDF File)
(Adobe PDF File)

2015 graduate celebration

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