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

Entry requirements for the programme normally specify a Science degree (at the equivalent of a 2.2 or above) and that the student has obtained basic knowledge about regulatory affairs processes, documentation in the healthcare industry and has professional skills which include attention to detail, organisation and communication in an area of healthcare product development and lifecycle management. 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
08/02/2021Drug–Device Combinations and Other TechnologiesModule 18 of the MSc and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.MC1820210
03/03/2021US Regulation of Medical DevicesModule 21 of the MSc and Masterclass: this will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market.MC212021O
01/12/2021Data Management and Digitalisation in Regulatory AffairsModule 12 of the MSc and Masterclass: This Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance).MSCM1221NE

Terms and conditions

Booking conditions for the MSc Regulatory Affairs modules.