Československý transplantační kongres
 |
|
1. československý transplantační kongres 2. československý transplantační kongres |
Konferenční abstrakta 2008
Abstrakta přednášek – sekce lékařů
EUSTITE INSPECTION GUIDELINES
1D. Fehily, 2J. Kurz, 3F. Teskrat, 4T. Hornez, 5J. Koller, 6C. Del Vecchio, 1A. Nanni Costa
1Centro Nazionali Trapianti, Italy, 2Federal Ministry of Health, Family and Youth, Austria, 3French Health Products Safety Agency, 4French Biomedicine Agency, 5University Hospital, Bratislava, Slovakia
• FNsP Bratislava, nemocnica Ruzinov, Ruzinovska 6, Bratislava
The development of guidelines for the inspection of tissue and cell procurement and tissue establishments is a key objective of the EUSTITE project (European Union Standards and Training for the Inspection of Tissue Establishments, www.eustite.org).
The guidelines aim to provide a frame-work for the way in which Competent Authorities in EU Member States regulate the implementation of the requirements of Directives 2004/23/EC, 2006/17/EC and 2006/86/ EC and will be produced in two editions. The first is based on a review of existing national and international guidance for the inspection of tissues and cells for human application and in related fields such as blood and pharmaceuticals. The second will be informed by a number of project activities including asurvey of current EU systems, an exploratory workshop with participants from many EU Member State Competent Authorities and a series of exchange visits between inspectors in Member States to observe each other’s practice.
AGuidelines Drafting Group has conducted the review of existing relevant documents for Edition I and produced a preliminary text and a number of subsequent revisions. Drafts have been circulated to project partners, key collaborators and stakeholders and to nominated Peer Reviewers for comment. Edition I of the EUSTITE inspection guidelines was submitted to the European Commission at the end of July 2007. Once comments and suggestions from the Commission have been received and incorporated, it will be circulated to all Competent Authorities in the EU. Edition II will be the subject of a full public consultation.
Within the EU, the organisations nominated as Competent Authorities vary considerably in terms of background, expertise and primary role.
Nonetheless, the work of the EUSTITE guidelines drafting group has shown that there are principles that all tissue and cell inspection systems should adopt and that the sharing of experience and ideas will facilitate the development of common approaches to regulation that reflect best practice.