Naslov
Vigilance: Lessons learned from the tissue and cell experiance in the European Union. Part I: Reporting and communication

Autori
1. Fehily, Deirdre ; Uhrynowska-Tyszkiewicz, Izabela ; Creusvaux, Hervè ; Pariente-Khayat, Ann ; Kaminski, Artur ; Olender, Ewa ; Manjaji, Elvira ; Swann, Imogen ; Sornarajah, Renuka ; Costello, Patrick ; Harkin, Donna ; Masterson, Sinead ; Alvarez, Marina ; Cantarero, Gregorio Garrido ; Smith, Mike ; Roels, Leo ; Teskrat, Fewzi ; O’Toole, Chris ; Funk, Markus ; Golubić Ćepulić, Branka ; Nikolac, Vanja ; Mareri, Maura ; Porta, Eliana ; Ghirardini, Angelo ; di Ciaccio, Paola ; Noel, Luc ; Nanni Costa, Alessandro

Izvornik
Organs, tissues and cells (1828-0595) 16 (2013); 165-173

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Vigilance, tissues, cells, serious adverse events

Sažetak
SOHO V&S (Vigilance and Surveillance of Substances of Human Origin) was a project co-funded by the European Union Public Health Programme. The project ran from March 2010 to February 2013. Its scope included tissues and cells for transplantation and gametes and embryos for assisted reproduction. The broad aim of the project was to support European Union Member States in the establishment of effective vigilance and surveillance (V&S) systems for tissues and cells used for human applications, including transplantation and assisted reproduction, ensuring the adoption of a common approach that would allow sharing of data and didactic information for the improvement of safety and quality. To achieve this broad objective, a number of key activities were carried out, including the development of guidance to EU Competent Authorities on the investigation and management of severe adverse reactions and events associated with tissues and cells for transplantation and for assisted reproduction. Equivalent guidance was developed for professionals in European Union hospitals and clinics who apply human tissues and cells to their patients. The latter guidance addressed the roles and responsibilities of clinical users in relation to supporting traceability and vigilance of tissues and cells for transplantation and assisted reproduction. This article, and its sister article (due to in March 2014), describe the key issues that arose and the conclusions reached in the development of these two guidance documents. This article describes the key points of guidance developed on reporting and communication of serious adverse events and reactions.

Izvorni jezik
Engleski

Znanstvena područja
Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)

POVEZANOST RADA