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
11/02/2025Regulatory Strategy for a New Active Substance NonclinicalThis 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. This  Masterclass is also Module 2 of the MSc.MC22025F
11/02/2025Regulatory Strategy for a New Active Substance NonclinicalThis 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. 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 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 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