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21 January 2008

European QP Association Plans on Launching an Interest Group for Advanced Therapies

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. Read the joint Commission and EMEA document.
Further information and respective guidance can be found on the EMEA website.
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.
QPs interested in setting up and contributing to this new Interest Group are requested to contact the Association under the following link: 

The following course has been compiled by the QP Association Advisory Board members for new and future Qualified Persons:
Qualified Person Education Course - Understand the Implications of Working as a QP
Vienna, Austria, 21-22 February 2008

It addresses general compulsory and regulatory issues to provide a general idea of the special tasks and responsibilities of a QP, but also to discuss and convey possible solutions to problems addressed in case studies and workshops.
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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