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
13/01/2026Data Management and Digitalisation in Regulatory AffairsGain the knowledge and practical skills to manage regulatory data in a digital world, from electronic submissions and eCompliance to regulatory information systems and IDMP implementation. This course is also Module 12 of the MSc programme. OnlineMSCM12225O
13/01/2026Data Management and Digitalisation in Regulatory AffairsGain the knowledge and practical skills to manage regulatory data in a digital world, from electronic submissions and eCompliance to regulatory information systems and IDMP implementation. This course is also Module 12 of the MSc programme.LondonUnited KingdomMSCM1225
27/01/2026Regulatory Environment in the Middle East and North AfricaMaster the complexities of the Middle East and North Africa's (MENA) evolving regulatory landscape and develop the insight to navigate regional challenges, drive compliance, and connect local developments to global strategies. This course is also Module 24 of the MSc programme. OnlineM24300725O
10/02/2026Regulatory Requirements for a New Active Substance: QualityGain the knowledge to interpret and advise on quality data requirements in pharmaceutical regulation, from manufacturing and validation to preparing CTD, IMPD and IND documentation. This Masterclass is also Module 3 of the MSc programme.FrankfurtGermanyMSCM32026F
10/02/2026Regulatory Requirements for a New Active Substance: QualityGain the knowledge to interpret and advise on quality data requirements in pharmaceutical regulation, from manufacturing and validation to preparing CTD, IMPD and IND documentation. This Masterclass is also Module 3 of the MSc programme. OnlineMSCM326O
24/02/2026The Regulatory Environment in South and East AsiaMaster the complexities of South and East Asia’s evolving regulatory landscape and develop strategies to support successful drug development across diverse markets. This Masterclass is also Module 25 of the MSc programme. OnlineM2525F2F
24/02/2026The Regulatory Environment in South and East AsiaMaster the complexities of South and East Asia’s evolving regulatory landscape and develop strategies to support successful drug development across diverse markets. This Masterclass is also Module 25 of the MSc programme.LondonUnited KingdomM2525O
03/03/2026Drug Device Combinations and Other TechnologiesGain the knowledge and skills to navigate the complex regulatory landscape for innovative medical technologies, including drug–device combinations and products manufactured using non-traditional processes. This course is also Module 18 of the MSc programme.LondonUnited KingdomMSCMD1826F
03/03/2026Drug Device Combinations and Other TechnologiesGain the knowledge and skills to navigate the complex regulatory landscape for innovative medical technologies, including drug–device combinations and products manufactured using non-traditional processes. This course is also Module 18 of the MSc programme. OnlineMSCMD1826O
24/03/2026The Regulatory Environment in the USAMaster the complexities of U.S. regulatory operations and gain the expertise to navigate FDA processes with confidence. This course is also Module 11 of the MSc programme.LondonUnited KingdomMSCM1126F
24/03/2026The Regulatory Environment in the USAMaster the complexities of U.S. regulatory operations and gain the expertise to navigate FDA processes with confidence. This course is also Module 11 of the MSc programme. OnlineMSCM1126O
28/04/2026Post-Market Surveillance and Vigilance for Medical DevicesStrengthen your understanding of vigilance and post-market surveillance (PMS) and learn how to apply these essential processes throughout the medical device lifecycle. This Masterclass provides a clear, practical introduction to PMS systems and vigilance procedures, with a strong focus on meeting European regulatory expectations. This course is also Module 16 of the MSc Regulatory Affairs.LondonUnited KingdomMSCMD1626F
28/04/2026Post-Market Surveillance and Vigilance for Medical DevicesStrengthen your understanding of vigilance and post-market surveillance (PMS) and learn how to apply these essential processes throughout the medical device lifecycle. This Masterclass provides a clear, practical introduction to PMS systems and vigilance procedures, with a strong focus on meeting European regulatory expectations. This course is also Module 16 of the MSc Regulatory Affairs. OnlineMSCMD1626O
19/05/2026Data for Abridged Applications and Specialised ProductsMaster the regulatory strategies and data requirements for abridged applications and specialised products, including herbals, drug–device combinations, radiopharmaceuticals, cosmetics, inhalation and blood products, while gaining the skills to provide confident, informed regulatory advice and navigate global submission pathways. This Masterclass is also Module 8 of the MSc programme.LondonUnited KingdomMSCM826F
19/05/2026Data for Abridged Applications and Specialised ProductsMaster the regulatory strategies and data requirements for abridged applications and specialised products, including herbals, drug–device combinations, radiopharmaceuticals, cosmetics, inhalation and blood products, while gaining the skills to provide confident, informed regulatory advice and navigate global submission pathways. This Masterclass is also Module 8 of the MSc programme. OnlineMSCM826O
29/06/2026Clinical Evaluation of Medical DevicesThis Masterclass will deepen your understanding of clinical investigation and the regulatory processes that support compliance, including alternative routes for demonstrating clinical evidence. This course is also Module 15 of the MSc programme.LondonUnited KingdomMSCMD1526F
29/06/2026Clinical Evaluation of Medical DevicesThis Masterclass will deepen your understanding of clinical investigation and the regulatory processes that support compliance, including alternative routes for demonstrating clinical evidence. This course is also Module 15 of the MSc programme. OnlineMSCMD1526O

 

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.