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A European Qualified Person Association is urgently needed!
The Qualified Person's function and responsibility is unique.
The European approach requires the QP not only to be highly qualified but also to always have the latest information on current developments in the area of GMP and regulatory compliance.
For this reason the ECA's Advisory Board Members decided at their annual meeting on 7 July 2006 to establish a new group: the European QP Association. With this association the ECA wants to provide QPs in Europe with a platform allowing them to exchange their experience, discuss the latest regulatory requirements, to identify and address difficulties and challenges and to support a harmonised European approach.
Today the European QP Association is led by six representatives from the industry and from authorities: Dr Bernd Renger (Chairman), Germany, Richard Bonner, UK, Dr Chris Burgess, UK, Martine Tratsaert, Belgium and Ian Thrussel, MHRA, UK, as well as Rudolf Völler from the GMP Inspectorate in Darmstadt, Germany.
Part of the organisation's activities is the organising annual forums as a platform to discuss current developments and challenges.
The inaugural QP Forum was held in Prague, Czech Republic, from 30 November to 1 December 2006. More than 150 delegates from 26 countries attended to be part of this first meeting of European Qualified Persons. The goal of the first meeting was to establish a platform for sharing experience and discussing the critical areas of the QP's daily work as well as roles and responsibilities of the QP with representatives from EMEA and national authorities. You will find more information about the Forums held so far in the
News/Publications Section.
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Conference in the US