On March 19, 2018, experts of the Pharmaceutical Activity Department took part in a masterclass organized by experts of the MHRA (Medicines & Healthcare products Regulatory Agency) on the procedure for amending registration dossier materials for medicinal products (Variations Masterclass and Workshop), in London, United Kingdom.
As part of the master class, experts who conduct the expert evaluation of registration dossiers shared their experience on the practical aspects of evaluating the quality data contained in registration dossiers. The Agency's experts highlighted key points of the procedure for the expert evaluation of type IA, IB, II changes, IB by default, and unforeseen changes, and provided advice on decision-making based on a risk-based approach strategy (a risk-based approach).
The department's experts obtained important information on the structure of European legislation, the classification of changes, grouping procedures (Grouping), and the worksharing procedure (Worksharing).
