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
7/26/2017Design Development and Certification of Medical DevicesGain 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.MC142017
9/6/2017Regulatory Strategy for a New Chemical Active SubstanceNon-Clinical Development: Module 2 of the MSc: The aims of this module are to enable you to consider and evaluate practical nonclinical regulatory aspects for global drug development, explore and critically debate the regulatory issues likely to arise during nonclinical programmes in order to be able provide effective advice on such situations.MSC22017
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
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