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Vigilance and Surveillance of Substances of Human Origin

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A final conference was held in Surrey, UK, to disseminate the key project outputs and review gaps and strategies for future work. It was attended by 85 regulators, vigilance officers, professional society representatives and experts in the fields of transplanted tissues, haematopoietic stem cells and ART from 18 EU MS as well as Switzerland, Croatia, the USA, Canada and Brazil. All 27 collaborating partner organisations were invited to send a representative. The project deliverables were presented and discussed in depth. The key achievements of the project include the development of guidance on:

  • V&S in Assisted Reproduction Technologies
  • Communication and Investigation of Adverse Reactions and Events
  • The Detection and Investigation of Suspected Illegal or Fraudulent Activity
  • V&S in Living Donors
  • V&S Guidance for Clinical Users

The first four guidelines have been printed in a single booklet that was provided to the delegates and can be downloaded as a pdf here:

The last one will be provided to Member State Competent Authorities as an electronic document for local adaptation, translation and distribution.

During the project, 2 training courses were organized and attended by 40 EU vigilance officers. The courses included a 4 week e-learning module followed by a short residential course. They represented an invaluable opportunity for vigilance officers to meet each other and share experiences.

At the Surrey conference some of the issues explored included

  • How best to engage clinicians in vigilance reporting and investigation
  • Approaches and methodologies for serious adverse incident investigation
  • The particularities of vigilance in the field of Assisted Reproduction
  • How to improve rapid urgent communication internationally
  • The challenges of communicating adverse outcomes to the public

Conference participants can download the conference presentations from the restricted area of this site. For further information on this project and its outputs cotact us as at

The SOHO V&S leaflet is now available:

Human Tissue Authority (HTA) has designed the SOHO V&S 'Lay-man's brochure', that will be used to present the project throughout its duration. See and download the electronic copy in the attachment below.

For hard copies, please contact:

Elvira Manjaji

Regulation Manager

Human Tissue Authority

151 Buckingham Palace Road, Victoria, London SW1W 9SZ

Tel: +44 20 7269 1939 Fax: +44 207 269 1999



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 7th to 9th 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.

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