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Konferenční abstrakta 2008
Abstrakta posterů – sekce lékařů
EUROPEAN UNION SYSTEM FOR THE STANDARDISATION OF TISSUE ESTABLISHMENT INSPECTION AND TRAINING OF INSPECTORS
1D. Fehily, 2J. Kurz, 3F. Teskrat, 4T. Hornez, 5J. Koller, 1C. Del Vecchio, 1A. Nanni Costa
1Centro Nazionali Trapianti, Italy, 2Federal Ministry of Health, Family and Youth, Austria, 3French Health Products Safety Agency, 4French Biomedicine Agency, 5University Hospital, Bratislava, Slovakia
• FNsP Bratislava, nemocnica Ruzinov, Ruzinovska 6, 826 06 Bratislava
To standardise and optimise systems for the authorisation of the tissue procurement and tissue establishments in the European Union:
The project is utilising th following tools to achieve these objectives: = survey =workshops =exchange visits =guidelines writing =vigilance and surveillance pilot = training courses.
To date the project has produced guidelines for inspection and a proposed model for the reporting and management of serious adverse events and reactions in the field.
EU funded projects can assist member states in the practical implementation of the recently adopted directives on the safety and quality of tissues and cells.