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European Union Standards and Training for the Inspection of Tissues Establishments [EUSTITE] [2005204] - Project
General objectives

A key specific objective of the project is to produce guidelines for the inspection of tissue establishments.

Strategic relevance and contribution to the public health programme

There is currently wide variation both in the approached being taken and in the stage of development of initiatives in the area of inspection and accreditation of tissue establishments and for surveillance of adverse events and reactions related to the quality of safety of the issues and cells provided in the various MS.
This project aims to promote standardisation to best practise in the inspection of tissue establishments and to develop optimal systems for the notification and management of adverse events and reactions related to the quality and safety of tissues and cells applied to patients in the EU.

Methods and means

A throrough review of current procedures and practise for the inspection and accreditation of tissue establishments will be conductes via a questionnaire survey and a series of exchange visits by inspectors to observe inspections in other MS. Two interactive workshops, one early and one later in the project, will analyse the different systems and procedures in place and under development and will aim to reach consensus on best practise.

Expected outcomes period

A group of experts will propose a system for the definitioin and classification of these occurrences and a model for notification and management which will be tested by the countries represented in the consortium. A final report and recommendations will be produced to contribute to future strategies for the surveillance of events and reactions related to the quality and safety of tissues and cells used in clinical application.

Details
Start date: 23/11/2006
End date: 23/11/2009
Duration: 36 month(s)
Current status: Finalised
Programme title: First Programme of Community action in the field of public health (2003-2008)
EC Contribution: € 1 226 827,00
Portfolio: Tissues and Cells