INTRO

Eustite stands for European Union Standards and Training in the Inspection of Tissue Establishments. The project is funded under the Public Health Programme of DG SANCO of the EC; it kicked off last December 1st 2006 and it will run for three years. The project is led by a partnership which is composed of 12 partners representing many national competent authorities for tissues and cells and the WHO. Key topics of this project are the drafting of European guidelines for the inspection of tissue establishments, the design of training courses for inspectors and the establishment of a system for the classification and reporting of adverse reactions and events associated with tissue and cell transplantation in MS.  Read more

latest news

The Eustite project has recently been presented to the firstmeeting of the MS Competent Authorities fortissues and cells in Brussels. The invitation was a recognition that Eustite is mandated to develop some of the activities foreseen in Directives 2004/23/EC, 2006/17/EC and 2006/86/EC, such as the drafting of EU inspection guidelines which the Commission may choose to present to the regulatory committee for adoption, the development of proposals for a EU system for the definition, classification and reporting of adverse events and reactions and the realization of a EU training course for inspectors. Read more

Eustite was invited to attend the latest European Assisted Conception Consortium (EACC) meeting that took place in Brussels on February 12th to report on the activities related to tissue establishment inspections. EACC has members including clinicians, regulators and scientists from many Member States and is working on the implementation of the tissues and cells directives, thus the work of Eustite, which also addresses inspection and adverse reaction and event reporting in the field of assisted conception, is of particular interest to this group. Read more

MAIN ARTICLE

The project activities are carried out by different working groups, whose members were identified according to their competencies and expertise in the field. Three working groups have already started their specific tasks: drafting the first edition of inspection guidelines; producing a survey on inspection systems in MS and initiating the work on vigilance and surveillance.The first working group is now gathering all relevant material from MS to produce the first edition of the inspection guidelines.  A first edition will be published in June 2007 and a second edition will  be published in 10 months time for a public consultation. Any interested party can participate to the consultation. Read more

The questionnaire survey will be distributed to all Competent Authorities directly by the organization leading this activity (ONT), or through the project partners by the end of March. The survey will investigate inspection systems applied in the Countries and it will represent a follow up of the EC questionnaire. Read more

Finally a review of systems for vigilance and surveillance is well underway and the Vigilance and Surveillance Medical Advisory Committee will meet for first time next March 5-6 in Madrid to consider the findings of this review and to begin to work on proposals for common definitions and classification of adverse reactions and events. This activity will also involve some particular experts from third countries, in order to have a global view. Read more

On May 22nd and 23rd the first Exploratory Workshop will take place in Dublin, organised by the Irish Medicines Board. The workshop aims at making an in depth analysis of inspection systems in EU Member States, including their reporting systems for adverse events and reactions and their systems to control tissue import/export. A large floor of experts and stakeholders will attend this event. Read more