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
30/10/2023The 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
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.MSCM1123O
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)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.IC12023
31/01/2024Data 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).MSC1224
31/01/2024Data 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).MSCM1224O
16/04/20242024 Spring Introductory CourseModule 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.IC042024
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
18/09/2024Regulatory 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
18/09/2024Regulatory 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