MSc Regulatory Affairs (Medicines)

TOPRA’s MSc Regulatory Affairs (Medicines) can be combined with a choice of up to two medical technology modules to give you more flexibility, so you can tailor the programme to your specific needs. The programme is validated by the University of Hertfordshire and allows you six years to complete the required elements. Students may also attain a Postgraduate Certificate after completing four modules or a Postgraduate Diploma after the completion of eight modules.

About the MSc

TOPRA is pleased to announce that our MSc Regulatory Affairs has been validated by the University of Hertfordshire.

The two 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. More

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.

Forms and documentation

Frequently asked questions

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

You can also contact Kay Wood, our postgraduate programmes administrator, for more details.

Fees

Experiences of the MSc

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

Upcoming modules

Begin DateTitleDescription
12/02/2020Regulation of In Vitro Diagnostic Medical DevicesThis Masterclass is also Module 19 of the MSc and is primarily focused on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions. This class is also module 19 of the TOPRA MSc Regulatory Affairs.MSCM1920
04/03/2020Design, Development and Certification of Medical DevicesThis Masterclass is also module 14 of the MSc Regulatory Affairs and will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.MC142020
03/06/2020Clinical Evaluation of Medical DevicesThis Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.MC152020
08/07/2020The Medical Device Introductory Course(Module 13 of the MSc Medical Devices) Providing those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU.INTROMD20
02/09/2020Post Market Surveillance and Vigilance for Medical DevicesThis Masterclass is also Module 16  of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the lifecycle of a medical device. This course will focus on meeting European requirements.MC162020
04/11/2020Regulatory and Related Activities Through the LifecycleThis Masterclass is also Module 17 of the MSc Regulatory Affairs and will provide regulatory affairs professionals with insight into the strategic issues affecting the commercial and regulatory maintenance of a medical device throughout its lifecycle, with focus on post-launch activities and future pressures.MC172020

Terms and conditions

Booking conditions for the MSc Regulatory Affairs modules.