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

TOPRA MSc fees guide 2018-2019
(Microsoft Word Document)

Experiences of the MSc

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

Upcoming modules

Begin DateTitleDescription
20/05/2019The Spring Introductory Course (Pharmaceuticals)An Introduction to Pharmaceutical Regulatory Affairs (Module 0 of the MSc Regulatory Affairs). This course covers all aspects of the product development process, and provides a sound overview of EU legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.IC12019
05/11/2019The Autumn Introductory CourseOur annual Autumn Introductory course is a comprehensive 4-day introduction to EU Pharmaceutical Regulatory Affairs (also Module 0 of the MSc Regulatory Affairs programme).IC219
08/05/2019Strategic Planning in Regulatory AffairsThis Masterclass will help you understand the practical and strategic aspects of global regulatory affairs, and enable you to develop your knowledge and skills to provide advice to your company to help develop a regulatory strategy. This is also Module 1 of the TOPRA MSc Regulatory affairs.MSC12019
03/07/2019Regulatory Strategy for a New Active Substance: NonclinicalThis Masterclass will give delegates an understanding of the practical and legislative requirements for the nonclinical phase of global drug development. It will explore the regulatory issues that are likely to arise and provide advice and discussion around solutions to such situations. This is also Module 2 of the TOPRA MSc Regulatory Affairs.MSC22019
04/12/2019Regulatory Requirements for a New Active Substance: QualityThis Masterclass will help you understand and provide advice on quality data requirements in the pharmaceutical regulatory environment as well as addressing practical regulatory questions in this area.  This is also Module 3 of the TOPRA MSc Regulatory Affairs.MSC32019
03/04/2019Registering Biological, Biotech & Advanced Therapy ProductsThis Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation and scientific principles underpinning development of biological, biotechnology and advanced therapy products, which provide challenges with their inherent complexities. The module includes consideration of the data requirements for clinical trial applications and marketing applications. This is also Module 9 of the TOPRA MSc Regulatory Affairs: The lecturers are highly experienced professionals in their field of work.MSC92019
20/11/2019Data Management and Digitalisation in Regulatory AffairsThis 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.  This is also Module 12 of the TOPRA MSc Regulatory Affairs.MSCM122019

Terms and conditions

Booking conditions for the MSc Regulatory Affairs modules.

2015 graduate celebration