MSc Regulatory Affairs (Medicines)


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The TOPRA MSc Regulatory Affairs (Medicines) has been running for more than 30 years. It is the go-to qualification for both established and new entrants in the profession as it is designed and delivered by expert practising regulatory professionals from a wide range of specialties and backgrounds.

Its flexibility and range are ideal for regulatory professionals who are looking for work-life balance and require a respected qualification that will support them in their career development. Its mix of theoretical, practical and strategic ensures that graduates are fully equipped to move rapidly, effectively and successfully along their desired career trajectory.

With up 22 modules (+ dissertation) available, students can tailor their programme to suit their specific needs, including the option to take up to two modules from the Medical Devices Pathway. This part-time programme allows you six years to complete the required elements.

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.

Students can opt to take a Postgraduate Certificate after completing four modules or a Postgraduate Diploma after the completion of eight modules.

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.  Full entry requirements

Forms, fees and documentation

Testimonials

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

Frequently asked questions

If you have a question about the TOPRA MSc, you may find the answer on our FAQ page. You can also contact Kay Wood, our postgraduate programmes administrator, for additional details.

Upcoming modules

Begin DateTitleDescription
02/11/2021The Autumn Introductory Course (Pharmaceuticals)Module 0 of the MSc: 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.VIC22021
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
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).MSCM1221O
02/02/2022Regulatory Requirements for a New Active Substance: QualityThis Masterclass is also Module 3 of the TOPRA MSc Regulatory Affairs and will help you understand and provide advice on quality data requirements in the pharmaceutical regulatory environment as well as address practical regulatory questions in this area.MSCM32022O
02/02/2022Regulatory Requirements for a New Active Substance: QualityThis Masterclass is also Module 3 of the TOPRA MSc Regulatory Affairs and will help you understand and provide advice on quality data requirements in the pharmaceutical regulatory environment as well as address practical regulatory questions in this area.MSC32022
28/03/2022The Spring Introductory Course (Pharmaceuticals)Module 0 of the MSc:  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.IC12022
16/05/2022Regulatory Strategy for a NAS: Global Clinical DevelopmentRegulatory Strategy for a New Active Substance: Global Clinical Development  is also Module 4 of the MSc and will help you to understand and develop regulatory strategies for all aspects of global clinical research, as well as address practical regulatory issues in this area.MSCM42022
16/05/2022Regulatory Strategy for a NAS: Global Clinical DevelopmentRegulatory Strategy for a New Active Substance: Global Clinical Development  is also Module 4 of the MSc and will help you to understand and develop regulatory strategies for all aspects of global clinical research, as well as address practical regulatory issues in this area.MSCM42022O
08/06/2022Regulatory Control of Clinical OperationsThis Masterclass is also Module 5 of the MSc and will provide you with an understanding of the practical and regulatory aspects of global clinical research, in order to offer effective advice on the regulatory issues likely to arise during clinical programmes.MSCM520222
08/06/2022Regulatory Control of Clinical OperationsThis Masterclass is also Module 5 of the MSc and will provide you with an understanding of the practical and regulatory aspects of global clinical research, in order to offer effective advice on the regulatory issues likely to arise during clinical programmes.MSCM522O
12/10/2022Regulatory Strategy for Established Active SubstancesThis Masterclass is also Module 7 of the MSc and is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of and 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.MSCM72022
15/11/2022The Autumn Introductory Course (Pharmaceuticals)Module 0 of the MSc: 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.IC22022
30/11/2022Regulatory Strategy From Development To the MarketplaceThis Masterclass is also Module 6 of the MSc regulatory Affairs and 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 lifecycle. You will 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.MSCM62022