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 12 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
2/14/2018Regulation of In Vitro Diagnostic Medical DevicesModule 19 of the MSc (Medical Devices) and Masterclass. Primarily focused 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 such as the US, Japan, China and Brazil.MC192018
2/28/2018Post-Market Surveillance and Vigilance for Medical DevicesModule 16 of the MSc (Medical Devices) and Masterclass. To define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the lifecycle of a medical device. The focus is on meeting European requirements.MC162018
4/11/2018The US Regulatory EnvironmentModule 11 of the MSc (Medicines) and Masterclass: The purpose of this module is to provide you with an understanding of the regulatory environment in the USA in order to place these global influences in perspective. As the largest single country market for pharmaceutical products, the regulatory requirements of the US FDA has a major influence on the design of pharmaceutical development programmes both within the USA and globally. This module offers an understanding of the US regulatory environment in order to place these global influences in perspective.MSCM112018
5/30/2018Regulatory 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
9/3/2018Drug 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
9/26/2018Regulatory Strategy From Development To the Market PlaceModule 6 of the MSc: This 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
10/24/2018Regulatory and related activities throughout the device lifeModule 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
11/28/2018Data 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
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