Contact: EDQM HelpDesk, OMCL Network
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:
ANSM - Direction des Laboratoires et des Contrôles – Lyon, France
ANSM - Direction des Laboratoires et des Contrôles – Montpellier, France
Istituto Superiore di Sanità, Italy
Centre for Biological Medicines and Medical Technology, BMT, Netherlands
Medical Products Agency, MPA, Sweden
Schweizerisches Heilmittelinstitut, OMCL Swissmedic, Switzerland
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.