European QP Association Plans on Launching Interest Group for Advanced Therapies

GMP News
24 January 2008
 

European QP Association Plans on Launching Interest Group for Advanced Therapies

 
In 2006, the first QP Forum of the new European QP Association took place inPrague, Czech Republic. During this Forum, an interest group was founded toaddress the needs of QPs working on Investigational Medicinal Products. Thefirst official meeting of this interest group was held as a Pre-ConferenceWorkshop as part of the 2007 QP Forum in Berlin, Germany.
 
Interest has now been expressed to set up a second Interest Group of the EQPAfocusing on Advanced Therapies. In case this proposal to set up a new InterestGroup is well received, it will be established and will help QPs in this area toexchange experience, ideas and insights.
  
Background on Advanced Therapies (Tissue Engineering, Cell Therapy and GeneTherapy):

The Regulation on advanced therapy medicinal products (Regulation (EC) No1394/2007) has been published on 10 November 2007 and will apply from 30December 2008. On 13 December 2007 DG Enterprise and Industry published itspriorities for the implementation of this Regulation. The implementation planhas been developed and agreed with EMEA.
 
The Regulation EC1394/2007 lays down specific rules concerning theauthorisation, supervision and pharmacovigilance of advanced therapy products.Central to the operation of this Regulation is the Committee for AdvancedTherapies (CAT) established as part of the EMEA. The joint Commission and EMEAdocument 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 interestrelates to the appointment by the European Commission of members and alternatesrepresenting clinicians and patients' associations at the Committee for AdvancedTherapies of the European Medicines Agency (EMEA). The public call is availablein 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 arerequested to contact the Association under the following link:
http://www.qp-association.eu/qpag_contact.html
 


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

 

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