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  • Created at 2016-02-04 12:20:49
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International collaboration for vigilance communication and preparation process development

This work package aims to increase the sharing of vigilance and clinical outcome information between MS to achieve higher standards of safety and quality across blood, tissues and cells.

One (Part A) will focus on increasing the involvement of EU MS Competent Authorities in the WHO’s Notify Library initiative, where adverse events and reactions of didactic value are evaluated to share the lessons learned as widely as possible, in support of improved safety and quality. The second (Part B) will explore the principles that should be applied for newly developed blood, tissue and cell preparation processes, in terms of recipient clinical follow-up, and the ways in which such data should be shared.