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In 2006, the first QP Forum of the new European QP Association took place in
Prague, Czech Republic. During this Forum, an interest group was founded to
address the needs of QPs working on Investigational Medicinal Products. The
first official meeting of this interest group was held as a Pre-Conference
Workshop as part of the 2007 QP Forum in Berlin, Germany.
Interest has now been expressed to set up a second Interest Group of the EQPA
focusing on Advanced Therapies. In case this proposal to set up a new Interest
Group is well received, it will be established and will help QPs in this area to
exchange experience, ideas and insights.
Background on Advanced Therapies (Tissue Engineering, Cell Therapy and Gene
Therapy):
The Regulation on advanced therapy medicinal products (Regulation (EC) No
1394/2007) has been published on 10 November 2007 and will apply from 30
December 2008. On 13 December 2007 DG Enterprise and Industry published its
priorities for the implementation of this Regulation. The implementation plan
has been developed and agreed with EMEA.
The Regulation EC1394/2007 lays down specific rules concerning the
authorisation, supervision and pharmacovigilance of advanced therapy products.
Central to the operation of this Regulation is the Committee for Advanced
Therapies (CAT) established as part of the EMEA. The joint Commission and EMEA
document is available here:
http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/docs/implementationplan-2007-12-11.pdf
The various linguistic versions of the regulation can be found here:
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev1.htm#reg1394_2007
Further information and respective guidance can be found on the EMEA website:
http://www.emea.europa.eu/htms/human/mes/advancedtherapies.htm
On 09/01/2008 the Commission published a public call for expressions of interest
relates to the appointment by the European Commission of members and alternates
representing clinicians and patients' associations at the Committee for Advanced
Therapies of the European Medicines Agency (EMEA). The public call is available
in all EU official languages:
http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/index.htm
QPs interested in setting up and contributing to this new Interest Group are
requested to contact the Association under the following link:
http://www.qp-association.eu/qpag_contact.html
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