Masterclasses

Our Masterclass courses are designed to meet the educational and vocational needs of experienced regulatory professionals in the pharmaceutical and allied industries.

Each pharmaceutical Masterclass lasts 2.5 days and is built around lectures, case studies and discussion groups. Lecturers are drawn from the industry, regulatory authorities and academia.

Emphasis in most of the courses is given to discussion of European regulatory requirements and to practical problems involved in meeting them. Where appropriate, comparisons are made with the regulatory requirements of other major markets.

A total of 23 continuing professional development Masterclasses are on offer providing the opportunity for experienced regulatory professionals to gain valuable in-depth knowledge and updates. Around five pharmaceutical Masterclasses are held each year.

Upcoming Masterclasses

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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.RotterdamNetherlandsMSCM1123
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. OnlineMSCM1123O
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.LondonUnited KingdomMSCRAM823
20/11/2023Design Development and Certification of Medical DevicesThis Masterclass (also module 14 of the MSc Regulatory Affairs) will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.LondonUnited KingdomMD142023
20/11/2023Design Development and Certification of Medical DevicesThis Masterclass is also module 14 of the MSc Regulatory Affairs and will help you to gain an understanding of the design, manufacturing and quality management requirements for product development, the importance and concepts of risk management and the ways in which risk is managed from the design stage onwards, so that you can provide appropriate advice on the key regulatory issues affecting design, certification and manufacturing of medical devices.Online MSC142023O
06/12/2023Drug Device Combinations and Other TechnologiesModule 18 of the MSc and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.LondonUnited KingdomMDM182023
06/12/2023Drug Device Combinations and Other TechnologiesModule 18 of the MSc and Masterclass: This module will enable you to consider and evaluate the practical regulatory aspects including the design, development and lifecycle of a medical device product.  MSCM1823O
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).LondonUnited KingdomMSC1224
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). OnlineMSCM1224O
24/04/2024Clinical Evaluation of Medical DevicesThis Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.LondonUnited KingdomMSCM152024
24/04/2024Clinical Evaluation of Medical DevicesThis Masterclass is also Module 15 of the MSc Regulatory Affairs and will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance. OnlineMSCM1524O
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.Online 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.LondonUnited KingdomMSCRA32024
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.LondonUnited KingdomMSCM12024
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. OnlineMSCM12024O
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. OnlineMSCM524O
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.LondonUnited KingdomMSCM52024
09/09/2024Registering 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.Online MSCM92024O
09/09/2024Registering 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.LondonUnited KingdomMSCM924F

 

Did you know taking Masterclasses can lead to achieving an MSc?

The programme is fully flexible part-time programme which can be spread over up to six years, so study at your own pace and pay as you go. Coursework assignments and the dissertation can be tailored to fit with the interests of the student or the needs of their company.

Find out more about our Qualifications opportunities.

Module schedule

The following table outlines the scheduling for all MSc modules through 2026.

Modules (by number)
Jan - Feb March - April May - July Sep - Oct Nov - Dec
 2021  8, 18 9, 21, 0, 10  19, 13, 1   22, 20, 2  0, 12
2022 3 0, 14  4, 5, 13, 15 7, 16 0, 17, 6
2023 21 2, 19, 0 9, 13, 20, 10   22, 11 0, 8, 18 
2024  12, 14  15, 0 3, 1, 5, 13  16, 6 0, 4, 17 
2025 2   0, 9, 19  7, 13  20, 22 5, 0, 21
 2026  12, 11 14, 0, 10  15, 3, 13  6, 18  0, 16, 8 

*This schedule is subject to minor changes.
Visit our Masterclasses page to see which modules are currently open for registration.