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
20/10/2021Regulatory 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.MC22021
20/10/2021Regulatory 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.MC22021O
02/11/2021The 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.IC22021
02/11/2021The 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.VIC22021
01/12/2021Data 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).MSCM1221NE
01/12/2021Data 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).MSCM1221O
02/02/2022Regulatory Requirements for a New Active Substance: QualityThis 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.MSCM32022O
02/02/2022Regulatory Requirements for a New Active Substance: QualityThis 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.MSC32022
28/03/2022The 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.IC12022
16/05/2022Regulatory 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.MSCM42022
16/05/2022Regulatory 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.MSCM42022O
08/06/2022Regulatory 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.MSCM520222
08/06/2022Regulatory 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.MSCM522O
12/10/2022Regulatory Strategy for Established Active SubstancesThis Masterclass is also Module 7 of the MSc and 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 OTC products. It will allow them to examine the regulatory requirements imposed on these substances.MSCM72022
15/11/2022The 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.IC22022
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