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Gene Therapy
OMCL join forces for the surveillance of the quality of gene therapy products
Contact: Helpdesk, OMCL network
Activities
In recent years, activities in the field of gene therapy (GT) have increased markedly. Large numbers of clinical trial applications are submitted to regulatory authorities and gene therapy products may soon be available on the market.
In order to prepare the OMCLs for their role in the surveillance of the quality of GT products, a specific Working Group has been established within the General European OMCL Network. The role of this Working Group is to foster collaboration between OMCLs working in the field of GT products in order to save time and resources by sharing knowledge and technologies.
Currently the following OMCLs participate in the Working Group:
• Danish Medicines Agency, Denmark
• AFSSAPS - Direction des Laboratoires et des Contrôles – Lyon, France
• AFSSAPS - Direction des Laboratoires et des Contrôles – Montpellier, France
• Paul-Ehrlich-Institut, Germany
• Istituto Superiore di Sanità, Italy
• Centre for Biological Medicines and Medical Technology, BMT, Netherlands
• INFARMED I.P. National Authority for Medicines and Health Products, Portugal
• Medical Products Agency, MPA, Sweden
• Schweizerisches Heilmittelinstitut, OMCL Swissmedic, Switzerland
• National Institute for Biological Standards and Control, UK
The GT Working Group meets once per annum to review the activities of the past year and to define the work programme of the following year as well as to discuss any relevant topics.
For more information please contact the EDQM Helpdesk
Additional Information & Documentation
The General European OMCL Network: background
Contact the EDQM Helpdesk
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
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