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 DateTitleDescriptionCityCountry
25/09/2019US Regulation of Medical DevicesThis Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. Additionally it will provide you with an understanding of a globally important market in addition to the knowledge of the EU that the rest of the course provides.This is also Module 21 of the MSc Regulatory Affairs.LondonUnited KingdomMSCM212019
20/11/2019Data Management and Digitalisation in Regulatory AffairsThis Masterclass will provide you with  the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance.  This is also Module 12 of the TOPRA MSc Regulatory Affairs.LondonUnited KingdomMSCM122019
04/12/2019Regulatory Requirements for a New Active Substance: QualityThis Masterclass will help you understand and provide advice on quality data requirements in the pharmaceutical regulatory environment as well as addressing practical regulatory questions in this area.  This is also Module 3 of the TOPRA MSc Regulatory Affairs.CheshamUnited KingdomMSC32019