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 DateTitleDescription
30/05/2018Regulatory Strategy for Established Active SubstancesModule 7 of the MSc (Medicines) and Masterclass: This module is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of 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.MSCM72018
03/09/2018Drug-Device Combinations and Other TechnologiesModule 18 of the MSc (Medical Devices) 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.MC182018
26/09/2018Regulatory Strategy From Development To the Market PlaceModule 6 of the MSc: This masterclass module 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 life-cycle and 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.MSCM62018
24/10/2018Regulatory and Related Activities in the Device LifecycleModule 17 of the MSc: This is the MSc module 'Regulatory Strategy in the Post-Market Phase'. It 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.MC172018
28/11/2018Data for Abridged Applications and Specialised ProductsModule 8 of the MSc: This module will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for abridged applications and specialised products, and explore and critically debate the regulatory issues likely to arise in order to be able to provide effective advice on such situations.MSCM82018