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 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

Begin DateTitleDescriptionCityCountry
12/05/2025The EU Paediatric RegulationThis Masterclass will enable delegates to understand the legislative framework and practical aspects of the EU Paediatric Regulation and considerations around designing paediatric clinical trials.LondonUnited KingdomM230525F2F
12/05/2025The EU Paediatric RegulationThis Masterclass will enable delegates to understand the legislative framework and practical aspects of the EU Paediatric Regulation and considerations around designing paediatric clinical trials. OnlineM230525O
23/07/2025US Regulation of Medical DevicesThis Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market.LondonUnited KingdomMSCM2125
23/07/2025US Regulation of Medical DevicesThis Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. This Masterclass is also Module 21 of the MSc. OnlineMSCM2125O
30/07/2025Regulatory Environment in the Middle East and North AfricaThis Masterclass provides regulatory affairs professionals with a comprehensive introduction to the evolving regulatory landscape in the Middle East and North Africa (MENA). Designed to deepen your understanding of regional frameworks and operational requirements, this course explores the unique challenges and opportunities across MENA markets. You’ll gain the insights needed to navigate this complex environment and place regional developments within a broader global context.LondonUnited KingdomM240725F2F
30/07/2025Regulatory Environment in the Middle East and North AfricaThis Masterclass provides regulatory affairs professionals with a comprehensive introduction to the evolving regulatory landscape in the Middle East and North Africa (MENA). Designed to deepen your understanding of regional frameworks and operational requirements, this course explores the unique challenges and opportunities across MENA markets. You’ll gain the insights needed to navigate this complex environment and place regional developments within a broader global context. OnlineM24300725O
08/09/2025Design Development and Certification of Medical DevicesThis Masterclass 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. OnlineMSC142025O
08/09/2025Design Development and Certification of Medical DevicesThis Masterclass 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 KingdomMSCM142025
16/09/2025Regulatory 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.LondonUnited KingdomM220225F2F
16/09/2025Regulatory 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. OnlineM222025O
07/10/2025The Regulatory Environment in South/East AsiaThis Masterclass will provide you with an understanding of the regulatory landscape across South/East Asia. This Masterclass is also Module 25 of the MSc. OnlineM2525F2F
07/10/2025The Regulatory Environment in South/East AsiaThis Masterclass will provide you with an understanding of the regulatory landscape across South/East Asia. This Masterclass is also Module 25 of the MSc.LondonUnited KingdomM2525O
20/10/2025Regulation of In-Vitro Diagnostics Medical DevicesThis module primarily focusing on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions. This Masterclass is also Module 19 of the MSc.LondonUnited KingdomMSCM1925
20/10/2025Regulation of In-Vitro Diagnostics Medical DevicesThis Masterclass primarily focusing on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions. This Masterclass is also Module 19 of the MSc.  MSCM1925O
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.LondonUnited KingdomMSCM1025
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.Online 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. OnlineMSCM12225O
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.LondonUnited KingdomMSCM1225
02/12/2025Regulation of Electrical, Electronic and Software DevicesThis Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impaally debate the commercial implications and the impact of the regulations on product stakeholders.LondonUnited KingdomMDM202025
02/12/2025Regulation of Electrical, Electronic and Software DevicesThis Masterclass will enable you to understand the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices. It will enable you to critically debate the commercial implications and the impact of the regulations on product stakeholders. This Masterclass is also Module 20 of the MSc.  MSCM2025O

 

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.