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
11/6/2017Clinical Evaluation of Medical DevicesThis will help you to understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.MC152017
11/27/2017Regulatory Strategy for a New Active Substance: GCDModule 4 of the MSc: This will enable you to develop effective regulatory leadership within your organisation throughout the clinical development and the registration of a new medicine.MSCM42017
1/31/2018Regulatory Control of Clinical OperationsModule 5 of the MSc (Medicines) and Masterclass: This module will provide you 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.MSCM52018
2/14/2018Regulation of In Vitro Diagnostic Medical DevicesModule 19 of the MSc (Medical Devices) and Masterclass. The course will cover both the current regulatory environment and the new medical device regulation in the EU and other jurisdictions such as the US, Japan, China and Brazil.MC192018
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
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