Public Health
Vigilance and Surveillance of Substances of Human Origin

Promoting Vigilance and Surveillance of Organs, Tissues and Cells

NOTIFY and the Bologna Results

From September 2010 to February 2011, the WHO, the CNT and the SOHO V&S project joined forces to organise a major global initiative aimed at raising the profile of V&S of substances of human origin; the initiative was called Project NOTIFY. The scope of the project included organs, tissues and cells for transplantation and for assisted reproduction. Dr Michael Strong was tasked by WHO with co-ordinating the work of 10 international expert groups. The work was conducted on a Google site where over 100 participants (regulators, clinicians, professional society representatives, scientific experts) collaborated to gather documented cases of reactions and events across the scope of the substances under consideration, using published articles and vigilance system reports as their sources. Almost 1400 published references were inserted on the site. The cases were used as the basis for developing draft guidance on detection and confirmation of reactions and events, with an emphasis on the key role of the treating physician. 

The NOTIFY project culminated in a meeting of 113 invited experts from 36 countries that took place in Bologna from February 7^th to 9^th 2011. The participants represented regulatory and non-regulatory government agencies, professional societies and scientific and clinical specialities from all WHO regions. The meeting was made possible with funds raised by CNT together with those allocated within the SOHO V&S project for an international meeting on vigilance reporting and investigation. The meeting explored the work already carried out on-line and agreed on priorities for the future development of global V&S for organs, tissues and cells. 

From the meeting, the Bologna Initiative for Global Vigilance and Surveillance (BIG V&S) was established and a number of outcomes will result:

· A detailed report of the meeting is being drafted and will be published. 

· The SOHO V&S project will propose instruments and guidance for tissue and cell V&S in the EU based on the outcomes of the Bologna Initiative. 

· WHO will publish a booklet for clinicians that will summarise the guidance on detection and investigation of adverse reactions and events that was developed by project Notify. The booklet will be provided to WHO Member States to promote V&S in transplantation. 

· A new dedicated site will be established by CNT, as part of a sustained collaboration with WHO, for the promotion of V&S. The ‘wiki’-style site will support the global dissemination of information and references regarding adverse events and reactions that have been documented for organs, tissues and cells. It will be publicly accessible and will be populated initially with all of the documented incidents already collected in the NOTIFY Google site. These cases, and new cases as they arise, will be posted on the site using key words and a minimum data set which will enable searching by, for instance, type of human substance, type of infectious disease transmission agent, type of logistical error etc. The tool will be a source of information for clinicians, potential donors and patients who wish to understand better the risks associated with particular types of donation or human application; for professionals who need information when deciding on the suitability of a potential donor and for regulators who need information on previous experiences of specific types of reported events and reactions.

· An international Steering Committee, under WHO and CNT, with regulatory and professional representatives from the fields of organs, tissues and cells, will be established to oversee the work of the new website and to take forward the other outputs of the Bologna Initiative including the development of correspondence tables for terminology and agreement on common definitions, where possible. 

This initiative will facilitate global sharing of V&S information and guidance for the enhancement of donor and recipient safety and for greater public transparency in transplantation and assisted reproduction. It will also support the development of internationally common, or corresponding, terminology for vigilance of organs, tissues and cells.