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 21 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
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.LondonUnited KingdomMC22021
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. OnlineMC22021O
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).LondonUnited KingdomMSCM1221NE
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). OnlineMSCM1221O
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.CheshamUnited KingdomMSC32022
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. OnlineMSCM32022O
23/03/2022Design, 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.LondonUnited KingdomMD1422
23/03/2022Design, 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. OnlineMSC142022O
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.BrusselsBelgiumMSCM42022
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. OnlineMSCM42022O
23/05/2022Clinical 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 KingdomMSCMD1522
23/05/2022Clinical 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. OnlineMSMD1522O
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.LondonUnited KingdomMSCM520222
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. OnlineMSCM522O
05/09/2022Post-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 KingdomMD162022
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.LondonUnited KingdomMSCM72022
02/11/2022Regulatory & Related Activities Through the Device LifecycleThis Masterclass is also Module 17 of the MSc Regulatory Affairs 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.LondonUnited KingdomMD172022
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.LondonUnited KingdomMSCM62022

 

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.