Modules of the MSc

The MSc Regulatory Affairs consists of a series of modules.

  • Five modules are offered per year
  • You can attend up to four modules per year
  • To gain your MSc you will need to attend eight modules within a minimum of 3 years and a maximum of 6 years
  • You must also submit a dissertation of 18,000–20,000 words.

All modules are also available as free-standing courses. If you wish to take a single module, please book it online .


Upcoming modules

Begin DateTitleDescription
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
30/11/2022Module 6 Accommodation De Vere Latimer Estate, UKThis 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.MSCM6ACCOM
15/03/2023Regulatory Strategy for a New Active Substance NonclinicalModule 2 of the MSc and Masterclass: This 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.MSCRAM223
15/03/2023Regulatory Strategy for a New Active Substance NonclinicalModule 2 of the MSc and Masterclass: This 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.MSCM223O
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
08/05/2023Leadership and Strategic Management in Regulatory AffairsModule 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
08/05/2023Leadership and Strategic Management in Regulatory AffairsModule 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