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EU Assessors Training on “Efficient and Effective Quality Assessment

The State Institute for Drug Control is organising the "EU Assessors Training on “Efficient and Effective Quality Assessment”. The training will be held from 19 th to 20 th April 2012 at the Hotel Crowne Plaza Prague Castle in Prague.

This meeting is meant to be a follow up to the quality assessors meetings held in The Hague in 2010 and in Vienna in 2011. The aim of Prague training remains the same with focus on risk based approach towards assessment, minimization of duplication of work within Europe and also alignment of requirements around Europe. Since the biggest part of assessor´s work is assessment of generic medicines this year training will be focused also on issues related to assessment of generics and in vivo- in vitro correlation, and properties of drug substance that can influence this correlation.


Information on registration for the training as well as on hotel reservation and other practical information can be found in the document “Practical Information” attached hereinunder.

Practical information

Klinické studie