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  • Created at 2016-02-04 12:20:49
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A voluntary programme of inter-inspection system auditing

The VISTART programm (16 MS are involved) are to promote and facilitate harmonisation of inspection, authorisation and vigilance systems for blood, tissues and cells and to increase inter-MS collaboration and confidence in each other’s inspections.

This action will include a number of initiatives aimed at increasing the interaction among inspectors from different MS including inspector training, a framework for joint inspections, a pilot for regional inspections by mixed MS teams and the creation of an inter-MS inspection system auditing programme. These initiatives will increase harmonisation, promote standardisation to best practice and increase mutual confidence.

This action through support for the harmonised implementation of the Single European Code (SEC) and its associated compendia of tissue establishments and tissue and cell products.

During this first decade of EU regulation in these fields, it has also become apparent that the EU has benefitted, and can benefit to a much greater extent, through sharing of information and discussion with colleagues outside the EU. The circulation of substances such as bone marrow, cord blood, bone, sperm and plasma for fractionation into and out of the EU highlights the need for compatibility of definitions, procedures and principles with those in place, or under development, in other parts of the world. Even in fields where significant international circulation is not seen, sharing of information through vigilance programmes has been an important source of practice improvement. This action will include an initiative to promote vigilance information sharing with the WHO vigilance didactic tool, the Notify Library, as well as supporting MS competent authorities to use the information in the tool to improve their vigilance investigation activities. It will also explore the development of enhanced vigilance, in the form of structured recipient follow-up, where tissue and cell preparation processes have been changed, an approach that has not been implemented on a EU level to date for any of these sectors.