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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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