Tools and Guidance for Vigilance and Surveillance
Last Updated ( Wednesday, 07 May 2008 )
The project’s 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 document can be downloaded from the V&S page of this site and comments should be sent to the project email address email@example.com.
Nominations for Eustite Training Courses Open
Last Updated ( Wednesday, 07 May 2008 )
The Eustite Training Courses for Inspectors will start in Mid June this year with the first e-learning module and the first residential course in Wien on September 8th – 11th. Three other courses will follow from Dember 2008 to Semptember 2009. Nominations to register to the courses are now open and can be sent through the Eustite email address. To get more information on the training program and to download the nomination form, please visit the page of the present website dedicated to the Training Courses.
Eustite posters presented in two congresses in April 2008
Last Updated ( Monday, 28 April 2008 )
On April 9th – 11th, edition ten of the Spanish Association of Tissue Bank congress took place in Valencia. See the website for complete program http://www.aebt.org/congreso2008/indice.htm. During this congress two posters on the Eustite project were submitted and presented: one describing the overal project (see poster) and the second presenting the results of the Survey of Existing Inspection Systems in Europe (see poster). This latter task was led by our Spanish partner, ONT.
The seventh International Donor Registriy Conference and Working Group Meetings – WMDA 2008 Congress – took place in Bern – Switzerland from April 16th to 19th 2008 (see www.wmda2008.org). A poster on the Eustite project, its objectives and results achieved so far was produced for the Congress (see poster). One of the Eustite representatives, Dr Johann Kurz from the Federal Ministry of Health, Family and Youth of Austria attended the Congress and represented the Eustite Poster.
Second meeting of NORPEP (NORdic Partnership of the Eustite Project
Last Updated ( Friday, 11 April 2008 )
The meeting on 10th April 2008 at the Swedish Society of Medicine in Stockholm, chaired by Torsten Mossberg of the Board of Health and Welfare, was attended by twenty four representatives of the Competent Authorities for Denmark, Finland, Iceland, Norway and Sweden, with members of the Swedish Steering Committee. Attendees were updated, and actively enquired upon, the status of transposing the Tissue Establishment Directives into national regulations, the types of tissues establishments and the progress with site authorisations. The afternoon sessions focused on the management of national inspection systems, the background and training of inspector’s and the mechanisms for site authorisations. The guest speaker, Deirdre Fehily, presented an insight to the Eustite work programmes with emphasis on Edition II of the Inspection Guidelines and the forthcoming voluntary pilot phase of the Vigilance & Surveillance for SAR’s and SAE’s by Competent Authorities. In line with the NORPEP objectives views were mutually exchanged on achieving blood samples from deceased donors within a 24hr period, risk assessments for stored tissues and cells, environmental standards for IVF clinics, commercial distributors of human tissues, and other matters. Proposals for future collaboration by NORPEP members – by further exchanges of experiences, reciprocal observer inspections and participation in EUSTITE activities – were welcomed.
Inspection Guidelines Edition II Launched for Open Consultation
Last Updated ( Sunday, 09 March 2008 )
The project reaches an important milestone with the release of Edition II for Consultation. This edition includes a number of enhancements, mostly derived from comments received on Edition I. There are a number of new annexes including a proposed common format for a Tissue Establishment Authorisation Certificate, a Preparation Process Dossier and an Aide Memoire for the inspection of ART centres. Comments on this draft document are welcome from any interested persons or organisations. The closing date for this consultation is April 4th. Comments should be emailed to firstname.lastname@example.org. Once the consultation is closed, all comments will be reviewed and a final version produced for presentation to the Meeting of Competent Authorities for Tissues and Cells. To download the documents, go to the Inspection Guidelines page or to the Public Documents page.