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Vigilance and Surveillance of Substances of Human Origin [SOHOV&S] [20091110] - Project
General objectives

The aim of SOHOV&S is to support EU MS in the establishment of Vigilance and Surveillance(V&S)systems for tissues and cells in transplantation and in assisted reproduction. MS with most experience will facilitate less experienced in the implementation of systems. The guidance can be translated and used as basis for national procedures. The training will ensure that officials who have recently been given these responsibilities will quickly be able to fulfil them. The project will drive harmonisation in terminology, investigation approaches, facilitating communication and cross-border management of serious adverse events and reactions (SAR/E). WHO involvement will extend this outcome to a global scale. The training will provide EU investigators to react effectively and efficiently to SAR/E. The guidelines for clinical users will support MS in the efforts to inform clinicians of roles and responsibilities in relation to V&S. Awareness on V&S will be raised via the project website and the enhancement of the Eurocet platform to include data on V&S activities.

Strategic relevance and contribution to the public health programme

This project is working to develop a shared view of how SAR/E, associated with tissue and cell donation or human application, are reported, evaluated and investigated. Tissues and cells for human application represent one of the key areas where the EU has introduced legislation to protect public health. It requires MS to establish systems for reporting of SAR/E and for forwarding an annual report of this activity to the Commission. The Work Plan for 2009 for the implementation of the second programme of Community action in the field of health (2008 to 2013) at 3.2.2.4. stated that `On blood and tissues and cells specific questions remain on the reporting systems and rapid response to serious adverse events and reactions and coding. Projects will be prioritised to help developing methodologies in this area`. Thus, this project is entirely in line with the Health Programme Work Plan.

Methods and means

The project objectives will be achieved using a number of different methods.
The guidance will include:
- interactive brain-storming and case study in exploratory workshops
- questionnaire survey on the current situation
- consultation with experts and stakeholders
- review of national or international guidance
Training will be delivered using:
- an e-learning platform (50 - 60 hours)
- 2 day residential courses.
Global networking will be achieved using:
- invitation of third country experts to key events
- consultation with key third country regulators on draft documents
- publication and presentation at international meetings
- a conference with discussions, posters and workshops.
Dissemination will be achieved using:
A website with e-newletters, enhancement of the Eurocet platform to include V&S information, journals, guidance documents, conferences, a brochure and a guidance booklet for hospitals and clinics.
Management will be achieved by regular meetings, reports, email correspondence, teleconferencing and sharing of documents on the reserved area of the website.

Expected outcomes period

At community level, there will be a shared view of how SAR/E should be investigated and reported. An EU network of officers and investigators will enhance management of incidents involving cross-border distribution of tissues and cells. MS will have a shared strategy for investigating, managing and communicating illegal and fraudulent activity. At national level, MS setting up new V&S systems in the field will have guidelines as basis of their procedures and policies. For the general public, there will be enhanced transparency in the risks associated with tissue and cell transplantation and assisted reproduction with information available on enhanced Eurocet platform. The promotion of the organisations monitoring vigilance programmes will increase confidence. From a global perspective, the WHO will be able to use the principles to promote V&S in the field of tissues and cells and to support this aspect of developing regulatory programmes around the world.

Details
Start date: 01/03/2010
End date: 01/03/2013
Duration: 36 month(s)
Current status: Finalised
Programme title: Second Programme of Community action in the Field of Health 2008-2013
EC Contribution: € 794 313,00
Portfolio: Tissues and Cells