The MSc Regulatory Affairs (Medicines) was introduced in 1989. This part-time course is designed to meet the postgraduate educational and vocational needs of personnel employed in the field of Regulatory Affairs in the pharmaceutical and allied industries. The MSc Regulatory Affairs (Medical Devices) was introduced in 2018.
Both degrees are organised and operated by TOPRA – The Organisation for Professionals in Regulatory Affairs. They are validated by the University of Hertfordshire.
Who is the MSc programme for?
The programme is designed for professionals working in Regulatory Affairs who have already gained first-hand experience of handling regulatory issues. Such experience may be in one area of Regulatory Affairs that could be developed and broadened by studying for the MSc. Alternatively, your experience may cover a wide regulatory area but would benefit from the in-depth considerations of the topics covered in the course.
Completing the MSc Regulatory Affairs has offered me the opportunity to expand my job responsibilities into new areas after completing relevant modules. It also enabled me to create an excellent network within the pharmaceutical industry, both by meeting other regulatory professionals at the modules and by interacting with industry experts while completing my dissertation research."
Studying for the MSc can therefore benefit the younger person at a relatively early stage in their career in Regulatory Affairs, or the more mature person who has perhaps worked in other industrial functions before specialising in Regulatory Affairs.
Students can also gain an interim award of a Postgraduate Certificate in Regulatory Affairs after completion of four modules, or a Postgraduate Diploma in Regulatory Affairs after the completion of eight modules.
Standalone modules can also be studied for continuing professional development (CPD).
Course structure
Five modules, each lasting 2.5 days, are held per academic year. Twelve modules of relevance to the pharmaceutical industry have been established. For those with limited experience of Regulatory Affairs, the Introductory Course is offered twice yearly, in Spring and Autumn.
To obtain the MSc Regulatory Affairs a student, who may enrol at any module, must take eight modules over a maximum period of six years and satisfy the other requirements stated in the schedule of assessment, including the completion of a research-based dissertation.