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
4/16/2018The Spring Introductory CourseIntroduction to Pharmaceutical Regulatory Affairs (Module 0 of the MSc Regulatory Affairs)IC12018
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
9/26/2018Regulatory Strategy From Development To the Market PlaceModule 6 of the MSc: This module will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for commercialising products and maintaining the brand from the development stages to registration and throughout the product life-cycle and explore and critically debate the regulatory issues likely to arise prior to and during commercialising of products in order to be able to provide effective advice on such situations.MSCM62018
5/30/2018Regulatory Strategy for Established Active SubstancesModule 7 of the MSc (Medicines) and Masterclass: This module is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of the strategic issues to be considered in relation to medicines containing established active substances, including; line extensions, generics and the relevant aspects for OTC products. It will allow them to examine the regulatory requirements imposed on these substances.MSCM72018
11/28/2018Data for Abridged Applications and Specialised ProductsModule 8 of the MSc: This module will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for abridged applications and specialised products, and explore and critically debate the regulatory issues likely to arise in order to be able to provide effective advice on such situations.MSCM82018

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.


Fees

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.


Downloads

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

2015 graduate celebration

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