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 a work-life balance and require a respected qualification that will support them in their career development. Its mix of theoretical, practical and strategic elements ensure that graduates are fully equipped to move rapidly, effectively and successfully along their desired career trajectory.

With up to 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.

Testimonials

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

Entry requirements

Entry requirements for the programme normally specify a Science degree (at the equivalent of a 2.2 or above), basic knowledge about regulatory affairs processes, documentation in the healthcare industry and professional skills which include attention to detail, organisation and communication in an area of healthcare product development and lifecycle management.  Full entry requirements

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 Rachel Hynes, our postgraduate programmes administrator, for additional details.

How to apply

Please download the application form and submit the completed form as instructed in the application documentation.

Download the application

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Forms, fees and documentation

Upcoming modules

Begin DateTitleDescription
28/03/2023The 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.IC22023P
09/05/2023Leadership and Strategic Management in Regulatory AffairsThis course was previously advertised for 8th-10th May, but has been changed due to the new UK Bank Holiday. Module 10 of the MSc and Masterclass: This Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment.MSCM1023O
09/05/2023Leadership and Strategic Management in Regulatory AffairsThis course was previously advertised for 8th-10th May, but has been changed due to the new UK Bank Holiday. Module 10 of the MSc and Masterclass: This Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation.  The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment.MSCRAM1023
15/05/2023Registering Biological Biotech & Advanced Therapy ProductsModule 9 of the MSc and Masterclass: 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.MSCM92023
15/05/2023Registering Biological Biotech & Advanced Therapy ProductsModule 9 of the MSc and Masterclass: 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.MSCM923O
27/06/2023The 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.MD2023
06/09/2023Regulatory Requirements for Cell Tissue & Gene TherapiesModule 22 of the MSc and Masterclass: Designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products, which has grown in significance over the past five years. It fills a gap in the educational needs for contemporary regulatory affairs specialists. It will allow students to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved.MSCM2223
06/09/2023Regulatory Requirements for Cell Tissue & Gene TherapiesModule 22 of the MSc and Masterclass: Designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products, which has grown in significance over the past five years. It fills a gap in the educational needs for contemporary regulatory affairs specialists. It will allow students to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved.MSCRAM2223
30/10/2023The US Regulatory EnvironmentThis Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of regulatory operations in the US.  This is also Module 11 of the TOPRA MSc Regulatory Affairs.MSCM1123
08/11/2023Data for Abridged Applications and Specialised ProductsModule 8 of the MSc and Masterclass: Learn to consider and evaluate the practical regulatory aspects of regulatory strategy and data requirements for abridged applications (generics), specialised products (herbals, drug-device combination, radiopharmaceuticals, cosmetics, inhalation and blood products) and strategic issues of abridged US options.MSCM823O
08/11/2023Data for Abridged Applications and Specialised ProductsModule 8 of the MSc and Masterclass: Learn to consider and evaluate the practical regulatory aspects of regulatory strategy and data requirements for abridged applications (generics), specialised products (herbals, drug-device combination, radiopharmaceuticals, cosmetics, inhalation and blood products) and strategic issues of abridged US options.MSCRAM823
14/11/2023The Autumn Introductory Course (Pharmaceuticals) 2023Module 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.IC12023