The EUSTITE project partnership met for the first time on December 11^th and 12^th 2006 at the National Transplant Centre (CNT) in Rome.  The meeting was the first step in a three-year project but, nonetheless, it represented the culmination of a long period of planning and negotiation.  Once the contract with the European Commission was signed in November 2006, the project co-ordinator acted promptly to organise the first meeting of project partners so that work could begin as quickly as possible.

The meeting in Rome was very successful.  All partners succeeded in sending representatives despite the relatively short notice and the enthusiasm of the group was clearly evident.  Although Directive 2004/23/EC, and its associated technical directives, give a clear regulatory framework for tissue and cell procurement, processing, storage and distribution activity, partners noted that the approaches of individual Member States to implementation of systems for inspection of tissue establishments and management of vigilance and surveillance in the field were significantly varied.  The 10 competent authorities represented in the partnership are committed to finding a common and optimal approach to these activities which will be acceptable to all Member States so that a certified or licensed tissue establishment in one Member State will be equivalent to one in another Member State even if the respective inspectorates have very different backgrounds, perspectives and experience.  The contribution of WHO to the development of a common glossary and tools for the management of vigilance and surveillance activities and the need for these to be globally compatible with existing or developing systems was much appreciated by the partnership.  

A key theme of the meeting was the need for the project to maintain strong and effective links with a number of key organisations and entities outside the partnership without compromising the efficiency of the group by excessive enlargement of meetings. Primary among these organisations would be the Competent Authorities of Member States not represented in the partnership. The Danish partner is presently establishing a Scandinavian network (SCANPEP, the Scandinavian Partnership for the EUSTITE Project) to ensure effective communication and participation of non-partner Competent Authorities in that region. Other partners were encouraged to consider similar strategies for involving other Competent Authorities in their regions. 

The Pharmaceutical Inspectorate Co-operation Scheme (PIC/S) includes many EU members who are also nominated as inspectorates of tissue establishments under Directive 2004/23/EC. This organisation was recognised by the partnership as having a key role in providing guidelines and training for pharmaceutical inspectors in Europe and beyond and, indeed, it was noted that their Expert Circle in Blood and Tissues provides specalised training for tissue establishment inspection and plans to provide inspection guidelines for their members. PIC/S has appointed the representative of the French Health Products Safety Agency (AFFSPS) as a Liaison Officer to ensure optimal co-operation with the EUSTITE partnership. The partnership expressed a clear commitment to ensuring that the experience and expertise of PIC/S be fully accessed by the project through the PIC/S Liaison Officer and to an objective that the project outputs would be consistent with the standards and objectives of the PIC/S Expert Circle on Blood and Tissues.

Key stakeholders were identified as the various organisations that represent professionals providing tissue and cell procurement, processing, storage and distribution services. The European Society for Blood and Marrow Transplantation, for instance, is a professional/scientific organisation that runs an important scheme for audit and accreditation of haematopoietic stem cell (HPC) facilities (the Joint Accreditation Committee of ISCT and EBMT, JACIE). Many Member State Competent Authorities have opted to collaborate with JACIE in the regulation of HPC procurement and processing facilities. Work package plans demonstrated a commitment to the involvement of JACIE in many project activities to ensure that their specialist experience and expertise be fully utilised by the project.

Lead partners presented their plans for their project workpackages. Details of the work and outputs of each work package can be reviewed on the ‘Project’, ‘Tissue Establishment Inspection’ and ‘Vigilance and Surveillance’ pages of this website. The next meeting of the partners will take place in Dublin to coincide with an exploratory workshop on existing inspection methodologies being applied to tissue procurement and tissue establishments within the EU.