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 Zamzam , 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
15/05/2024Regulatory Requirements for a New Active SubstanceThis 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.MSCM2024O
15/05/2024Regulatory Requirements for a New Active SubstanceThis 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.MSCRA32024
05/06/2024Strategic Planning in Regulatory AffairsModule 1 of the MSc and Masterclass: This 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.MSCM12024
05/06/2024Strategic Planning in Regulatory AffairsModule 1 of the MSc and Masterclass: This 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.MSCM12024O
26/06/2024The 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.MDINTRO24
17/07/2024Regulatory 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.MSCM524O
17/07/2024Regulatory 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.MSCM52024
09/09/2024Registering 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.MSCM92024O
09/09/2024Registering 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.MSCM924F
07/10/2024Regulatory 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.MSCM62024F
07/10/2024Regulatory 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.MSCM62024O
12/11/2024Overview of EU Pharmaceutical Regulatory AffairsModule 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.IC22024
20/11/2024Regulatory 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.MSCM42024
20/11/2024Regulatory 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.MSCM42024O