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Vigilance & Surveillance Well on its Way |
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Tuesday, 31 March 2009 |
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At the half-way point of the V&S pilot, 22 Competent Authorities from 20 Member States are participating. The second quarterly reports have almost all been received by the pilot co-ordinator and a report of the first quarter has been compiled. In the first quarter 23 Serious Adverse Reactions (SAR) and 25 Serious Adverse Events (SAE) were reported to the pilot, including some very interesting cases. Some changes have already been made to the classification of reactions following experience gained from the first reporting quarter. The pilot has an identified contact person in each participating Competent Authority. These key individuals are crucial to the success of the project. They are applying the EUSTITE Severity and Imputability tools to each SAR reported in their Member State and the Impact Assessment Tool to both SAR and SAE. Their enthusiasm is much appreciated and they are enjoying being part of a new EU network of Tissues and Cells vigilance experts. Stephanie Sullivan, the Pilot Co-ordinator, has presented the pilot work to the International Haemovigilance Network (previously the European Haemovigilance Network) meeting in Rome at the end of February. |
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Last Updated ( Monday, 04 May 2009 )
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Inspector Training Courses - Half Way Through |
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Tuesday, 31 March 2009 |
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Two training courses out of four have been organized by the Eustite Team. Around 35 European inspectors have been trained between Austria and Bulgaria and it is planned that a total of 40 more inspectors will be trained before July 2009 in Denmark and in Italy. The first 2 courses were of a great success; participants gave very positive feed-back in terms of teaching methods and material and usefulness of the contents in their everyday practice. The remaining two training courses are already full-booked and, since there are already some applications on a waiting list, the Eustite Team is considering the possibility to organize extra courses during the year 2010. All CAs are therefore invited to continue submitting application forms to
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for inspectors wishing to be trained. The application form to use for the expression of interest can be downloaded from the present website. |
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Last Updated ( Tuesday, 31 March 2009 )
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European Union Standards and Training in the Inspection of Tissue Establishments - EUSTITE |
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Friday, 01 December 2006 |
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EUSTITE is a 3 year project that has been funded by the European Union following the publication of 3 EU directives defining minimum standards of quality and safety for human tissues and cells that are applied to patients for therapeutic purposes. Examples are corneas that are donated after death and transplanted to patients during eye surgery, donated bone marrow that is used to treat patients with leukaemia or donated sperm that is used in assisted conception procedures. The EU Directives require Member States to ensure that procedures for collecting, processing, storing and distributing these tissues and cells are compliant with the standards defined in the Directives so that patients are treated with tissues and cells that will function as intended and will be safe. The project proposes standardised guidelines for the conduct of inspections and tested tools for the training of inspectors in this field to support Member States in the implementation of these Directives. The project began on December 1st 2006 and was officially launched at a meeting of the partners in Rome on December 11th and 12th. |
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Last Updated ( Wednesday, 07 May 2008 )
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