Hello ruth warwick this is the latest Newsletter Release from Eustite Project
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Eustite Newsletter Date  May 7 2008 / Issue 4  

in tHIS ISSUE:  

  • EUSTITE TOOLS AND GUIDANCE FOR V&S - CONSULTATION ON PROPOSALS
 
  • V&S PILOT - inVITATION TO COMPETENT AUTHORITIES TO PARTICIPATE  
 
  • EUSTITE INSPECTOR TRAINING COURSES BEGIN - INVITATION TO COMPETENT AUTHORITIES TO NOMINATE PARTICIPANTS 

EUSTITE TOOLS AND GUIDANCE FOR V&S - CONSULTATION ON PROPOSALS

The projectís proposals for vigilance of tissues and cells in the EU are open to consultation until May 21st 2008. The proposals include criteria for the reporting of adverse events to Competent Authorities, tools for the assessment of severity, imputability and impact and guidance on the management of events and reactions, including those with cross border implications. The tools are designed to support compliance with the EU tissues and cells directives but an individual CA may require the reporting of events or reactions which fall beyond the scope of the European Directives. The tools will be applied in European Union Member States that participate in the EUSTITE Vigilance and Surveillance pilot which will run from July 2008 to July 2009. A final report and recommendations will be produced to contribute to future strategies for the surveillance of events and reactions related to the quality and safety of tissues and cells used in clinical application. The document can be downloaded from the EUSTITE website (Click Here). Comments should be sent to info@eustite.org.   

V&S PILOT - INVITATION TO COMPETENT AUTHORITIES TO PARTICIPATE

All EU Competent Authorities for tissues and cells are invited to participate in the EUSTITE V&S pilot that will apply the proposed tools for a one year period from July 2008 to June 2009. Participating Competent Authorities will identify a single contact person and submit quarterly returns of all Serious Adverse Events and Reactions reported to them using a custom-designed report form. The participating Competent Authorities will apply the tools as detailed in the Instructions to Participants. Participants will feed back to the project at the end of the period to allow conclusions and recommendations to be developed for submission to the European Commission. Competent Authorities who wish to participate should contact the project email address info@eustite.org

EUSTITE INSPECTOR TRAINING COURSES BEGIN - INVITATION TO COMPETENT AUTHORITIES TO NOMINATE PARTICIPANTS

A series of 4 training courses will be run during the last year of the project in four different countries: Austria, Bulgaria, Denmark and Italy. This activity is led by the Federal Ministry of Health, Family and Youth of Austria. Each course will consist of a 6 week e-learning module and a 3 day residential module. The e-learning module shall be completed by participants in the 2/3 months prior to the 3 day presence module. At each course, there will be 6 course instructors including an expert in the field of Assisted Reproduction regulation.

The first course will begin in Mid June 2008 with the e-learning module, followed by the residential course in Austria on September 8th to 11th. Competent Authorities can now send nominations for Inspectors to attend one of the four courses. The nomination form can be downloaded from the Eustite website (Click Here). The participants selection process for the first training course will close on June the 1st and each of the subsequent selection phases will close three months prior to the residential course, to allow participants to follow the e-learning module.

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E-mail: ruth.warwick@nhsbt.nhs.uk