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History:
Already at the first QP Forum 2006 in Prague Annemiek Stijnen and Martine
Tratsaert proposed to establish a Working Group within the European QP
Association. The EQPA generally supported this idea and therefore
decided to provide a platform for Working Groups and Interest Groups
inside the Association.
One year later, at the 2007 QP Forum in Berlin, the IMP Working Group
offered a Pre-Conference Workshop on 'Import Requirements for IMPs' and
'Handling of Comparators in Clinical Trials'. This workshop was also the
first official meeting of the group. The IMP Working Group also
facilitated one of the parallel sessions during the Forum, discussing
challenges of 'Being an IMP QP in a global environment.
During the Pre-Conference Workshop at the 2008 Forum in Munich, the
following topics were discussed: Interphase GMP-GCP, The role of the
hospital pharmacist and Phase 1 minimal requirements.
Today, the IMP Working Group is a well-established "sub-organisation"
and its Pre-Conference Workshop a well-known part of this annual QP
Association event. The workshop is also facilitated as an annual meeting
of the IMP Working Group and provides a very good opportunity for
networking and cultivating personal contacts.
To get more information on this year's workshop please see the
QP Forum programme.
Objectives:
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Exchange of experience
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Exchange of ideas/insights
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Discuss interpretation of regulatory guidance
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Discuss difficulties encountered in daily QP practice
and how to solve them
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Inform each other on country specific items (import,
export, views of regulatory authorities)
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Any other goals that the members may bring in
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Try to influence HA by providing valuable input to new
legislation
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Installing core team dealing with new legislation would
be an asset.
Management and Administration:
The IMP Working Group is lead by:
Martine Tratsaert, Johnson & Johnson, Belgium and
Annemiek Stijnen,
Kinesis Pharma, Netherlands.
Martine is also a member of the QP Association Advisory Board.
Their delegates are
May Smans, Johnson & Johnson (Qualified Person)
Janet Janssen, Kinesis Pharma (Consultant Chemistry,
Manufacturing and Control)
Administration work is provided by the EQPA Secretary. To become member of
the IMP Working Group please contact us via eMail: info@qp-association.eu
Please note that membership in this group will be granted to Members of
the QP Association only. |
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