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10 August 2006

European Compliance Academy (ECA) Advisory Board
Establishes European Qualified Person Association

The Qualified Person (QP) has a key function and responsibility in the pharmaceutical industry. As laid out in Article 49 of the European Parliament DIRECTIVE 2001/83/EC, he needs to be highly qualified and experienced. In addition, the QP also needs to be on top of current developments in GMP and regulatory affairs.

For that reason the ECA's Advisory Board Members decided in 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.

The new Association will be lead by four representatives from the industry and from authorities: Richard Bonner, UK, Dr. Bernd Renger, Germany and John Taylor, MHRA, UK as well as Rudolf Völler from the GMP Inspectorate in Darmstadt, Germany.

"Being the key person in the quality function of a pharmaceutical company, the QP has to consider lots of issues to fulfil his responsibilities and to comply with European legislation," said Dr. Bernd Renger, Director Quality Control at Vetter Pharma-Fertigung GmbH, Germany, and ECA Advisory Board Member. "Due to the increase and scope of these responsibilities we saw a need for a Europe wide exchange forum," he continued.

To accomplish its goals, the Association plans on organising annual QP Forums. The inaugural Qualified Person Forum will be held in Prague, Czech Republic, from 30 November to 1 December 2006.

Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)

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