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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.
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