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

Begin DateTitleDescriptionCityCountry
23/10/2024Post-Market Surveillance and Vigilance for Medical DevicesThis Masterclass is also Module 16 of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the life cycle of a medical device. This course will focus on meeting European requirements.LondonUnited KingdomMSCMD16F
23/10/2024Post-Market Surveillance and Vigilance for Medical DevicesThis Masterclass is also Module 16 of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the life cycle of a medical device. This course will focus on meeting European requirements.Online MSCMD16O
19/11/2024Regulatory 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.BerlinGermanyMSCM42024
19/11/2024Regulatory 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.Online MSCM42024O
04/12/2024Regulatory Strategy in the Post Market PhaseThis Masterclass is also Module 17 of the MSc Regulatory Affairs (previously know as Regulatory and Related Activities Through the Device Lifecycle) will provide regulatory affairs professionals with insight into the strategic issues affecting the commercial and regulatory maintenance of a medical device throughout its lifecycle, with focus on post-launch activities and future pressures.LondonUnited KingdomMD172024
04/12/2024Regulatory Strategy in the Post Market PhaseThis Masterclass is also Module 17 of the MSc Regulatory Affairs (Previously titled Regulatory & Related Activities Through the Device) and will provide regulatory affairs professionals with insight into the strategic issues affecting the commercial and regulatory maintenance of a medical device throughout its lifecycle, with focus on post-launch activities and future pressures.Online MD172024O
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.Online 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.LondonUnited KingdomMSCM72025F
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. OnlineMSCM72025O
03/06/2025US 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.LondonUnited KingdomMSCM2125
03/06/2025US 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.  MSCM2125O
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 MScLondonUnited 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.OnlineUnited KingdomMSCM1025O
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.