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

  Fees

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
11/02/2025Regulatory Strategy for a New Active Substance Non-clinicalThis Masterclass will give delegates an understanding of the practical and legislative requirements for the non-clinical 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  Masterclass is also Module 2 of the MSc.MC22025F
11/02/2025Regulatory Strategy for a New Active Substance Non-clinicalThis Masterclass will give delegates an understanding of the practical and legislative requirements for the non-clinical 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 Masterclass is also Module 2 of the MSc.MC22025O
01/04/2025Regulatory Strategy for Established Active SubstancesThis Masterclass 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 over-the-counter (OTC) products. It will allow them to examine the regulatory requirements imposed on these substances. This Masterclass  is also Module 7 of the MSc.MSCM72025F
01/04/2025Regulatory Strategy for Established Active SubstancesThis Masterclass 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 over-the-counter (OTC) products. It will allow them to examine the regulatory requirements imposed on these substances. This Masterclass is also Module 7 of the MSc.MSCM72025O
15/04/2025Overview 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.IC042025
12/05/2025The EU Paediatrics RegulationThis Masterclass  will help you to gain an understanding of . This Masterclass is  also Module 23 of the MSc.M230525F2F
12/05/2025The EU Paediatric RegulationThis Masterclass will help you to gain an understanding of This Masterclass is  also Module 23 of the MSc.M230525O
16/06/2025The Medical Device Introductory CourseThis Masterclass will provide those new to Medical Device Regulatory Affairs with an understanding of the regulatory requirements for medical devices in the EU. This Masterclass is  also Module 13 of the MSc.MDINTRO25
01/07/2025Regulatory 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.M220225F2F
01/07/2025Regulatory 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.M222025O
30/07/2025Regulatory Environment in the Middle East and North AfricaThis Masterclass  will help you to gain an understanding of . This Masterclass is  also Module 24 of the MSc.M240725F2F
30/07/2025Regulatory Environment in the Middle East and North AfricaThis Masterclass  will help you to gain an understanding of . This Masterclass is  also Module 24 of the MSc.M24300725O
30/09/2025The Regulatory Environment in South/East AsiaThis Masterclass will help you to gain an understanding of This Masterclass is  also Module 25 of the MSc.M2525F2F
30/09/2025The Regulatory Environment in South/East AsiaThis Masterclass  will help you to gain an understanding of . This Masterclass is  also Module 25 of the MSc.M2525O
04/11/2025Overview 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.IC0112025
10/11/2025Leadership and Strategic Management in Regulatory AffairsThis 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. This Masterclass is also Module 10 of the MSc.MSCM1025
10/11/2025Leadership and Strategic Management in Regulatory AffairsThis 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. This Masterclass  is also Module 10 of the MSc.MSCM1025O
18/11/2025Data 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 Masterclass is also Module 12 of the MSc.MSCM12225O
18/11/2025Data 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 Masterclass is Module 12 of the MSc.MSCM1225