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.
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.
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.
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
