Title of Presentation
“General quality management system requirements for European biobanks: focus on formalin-fixed and paraffin-embedded tissues”
Date and Place
Serena Bonin graduated in Chemistry at the University of Trieste and obtained the PhD in life sciences at the Open University of London. Since 1997 she has been assistant professor at the Department of Medical Sciences of the University of Trieste. She has also been involved in teaching in courses and since 2003 she’s been member of the teaching board of the School of Doctorate of Nanotechnology.
Her main research activities are focused on the study and application of molecular analyses in biomolecules from formalin fixed paraffin embedded tissues, in particular RNA. She is part as an expert in the Biobanking and Biomolecular Resources Research European Infrastructure (BBMRI-ERIC). She is co-chair of Working Group 2 (FFPE tissues) in the BBMRI- ERIC program on quality management, aiming to harmonise CEN Standards for European biobanks. She is the author of more that 100 scientific publications on international journals, book chapters and conference proceedings.
The European Committee for Standardization (CEN) recently published Technical Specifications on “Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for different sample types”. These Technical Specifications (CEN/TS) serve as basis for evaluating the performance, quality, and comparability of European biobanks. BBMRI-ERIC´s work plan on quality has set up expert working groups for reviewing the CEN/TS with regard to the applicability for European biobanks. The Working Group 2 focuses on the pre-analytical phase for formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA, RNA, and protein analysis. Up to now 7 web conferences with more than 17 partners and several person-to-person meetings with the group members were held. As the CEN documents are the basis for upcoming International Standards of the International Standardisation Organisation (ISO) – which are currently at the Draft International Standard stage – the working groups of BBMRI-ERIC will contribute with their feedback to further improve upcoming ISO International Standards. A self-assessment-tool based on sample processing procedures is under development and will enable European biobanks to assess whether their own Standard Operating Procedures (SOP) are in line with the requirements of the CEN/TS or which steps need to be adjusted. The working group closely interacts with the activities of the different National Nodes (BBMRI.xx) for improving QMS in their biobanks. General QMS requirements will be drafted and made available to support European biobanks in improving their individual work flows together with their academic and industrial partners for designing better diagnostic tools and establishing more specific therapies.