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BBMRI.QM Training & Education

on the ISO standards for

Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for

 

Frozen tissue:

Isolated RNA, ISO 20184-1

Isolated proteins, ISO 20184-2

Formalin-fixed and paraffin-embedded tissue:

Isolated RNA, ISO 20166-1

Isolated proteins, ISO 20166-2

Isolated DNA, ISO 20166-3

Venous whole blood:

Isolated cellular RNA, ISO 20186-1

Isolated genomic DNA, ISO 20186-2

Isolated circulating cell free DNA from plasma, ISO 20186-3

 

The BBMRI.QM team provides in cooperation with the H2020 project SPIDIA4P GA 733112, an in-depth training on the pre-analytical standards  relevant for biomedical research and biobanking.

This BBMRI.QM training & education programme will be presented as a virtual training, split into 16 sessions in which the individual chapters of the standards will be discussed. Renowned experts will give comprehensive presentations on requirements, definitions and practical applications.

 

Registration

 

Registration desk

 

A prerequisite for active participation is the possession of the relevant ISO standards.

Until November 20, 2020, Austrian Standards offers you a price reduction of up to 50 % when ordering preanalytical ISO standards & ISO 15189, in English and/or German version.
More about the offer and how to place an order here.

For more information, please contact: Ulrike Rohrer ulrike.rohrer@bbmri-eric.eu

BBMRI-ERIC is member state driven, serving public organisations (universities, hospitals, biobanks and their associated researchers). Within our member and observer countries we are offering free access to our services. No free access for private sector (industry, business enterprise, SMEs, etc.), access on request.

Speakers

Uwe Oelmueller, Dr.

Uwe Oelmueller joint QIAGEN in 1995. He currently heads the global Molecular Diagnostics Technology Center for Sample Technologies. At the QIAGEN / BD joint venture company PreAnalytiX he is QIAGEN’s management committee co-chair. The company develops and sells integrated systems for sample collection, stabilization and purification of nucleic acids from clinical specimens. Dr. Oelmueller was the coordinator of the EU FP7 Collaborative Grant Project SPIDIA (2008 – 2013) and is the current coordinator of the EU Horizon 2020 Coordination and Support Action SPDIA4P (2017 – 2020). Both projects focus on the standardization and improvement of pre-analytical workflows for in-vitro diagnostics. He is a working group convener at the ISO/TC 212 (clinical Laboratory testing and in vitro diagnostic test systems) and at the CEN/TC 140 (in vitro diagnostic medical devices). In 2017 he received the “DIN Honorary Needle” Award for his international engagement in standards developments for quality management in medical laboratories and in 2020 the “Standard + Innovation Award” from the European standards body CEN-CENELEC for his contributions of research and innovation to standardization.

Peter Riegman, PhD

Peter Riegman is a molecular biologist. 1982-1986: Study Biology Leiden University 1986-1992: Ph.D. study: Prostate-Specific Antigen at Erasmus University Rotterdam; Promotor: Prof. Dr. D. Bootsma, Co-promotor: Prof. Dr. J. Trapman; 1992-1997: Postdoc: meningioma and neurofibromatosis at Erasmus University Rotterdam; Dr. E. Zwarthoff; 1997-2001: Postdoc, neoplastic progression in Barrett’s Esophagus at Erasmus University, Rotterdam; Dr. H van Dekken.
From 2001 – present: He is the head of the Erasmus MC Tissue Bank at the Pathology Dept, Erasmus Medical Center, Rotterdam, where he became involved in European projects: TuBaFrost as coordinator, EuroBoNeT, BBMRI, BIOPOOL, SPIDIA, EurocanPlatform as WP leader of Biobanking. Since 2017 he is active in SPIDIA4P as WP leader in ethics/rules and regulations and from the start of 2020 in Instand-NGS4P as WP4 leader. In 2010 he was ISBER president and ESBB president in 2011 He became Section editor of Biopreservation and Biobanking.  From 2012 Erasmus MC Health RI parelsnoer UMC and biobank coordinator as well as NEN commissioner in CEN/TC140WG3 and ISO/TC212WG4. In 2018 he became advisor in the Erasmus MC service platform project team Erasmus MC Central Biobank.

Kurt Zatloukal, Prof. MD

Kurt Zatloukal, MD is professor of pathology at the Medical University of Graz, Austria and head of the Diagnostic and Research Center for Molecular BioMedicine. His research focusses on molecular pathology of diseases as well as biobanking and related data management technologies. He coordinated the preparatory phase of the European biobanking and biomolecular research infrastructure (BBMRI-ERIC) and is director of the Austrian national node BBMRI.at. He directed the Christian Doppler Laboratory for Biospecimen Research and Biobanking Technologies. He contributes to the development of new European standards and norms for pre-analytical processing of tissue samples for molecular testing and is member of the Austrian Standards Institute and of the scientific board for genetic testing and human gene therapy at the Austrian Ministry of Health. He was member of the OECD task force on biological resource centres and the Roadmap Working Group of the European Strategy Forum on Research Infrastructures. He is Member of the Academia Europaea, corresponding member of the Austrian Academy of Sciences, and has published over 215 scientific papers and was co-inventor of 25 patent applications.

Cornelia Stumptner, MSc

Cornelia Stumptner is manager of the BBMRI.at project since 2013. She holds a Master’s degree in international marketing management and sales and a degree in Biomedical Analytics. Before her management position in BBMRI.at, C. Stumptner has been working in biomedical research at the Institute of Pathology (Med Uni Graz) for more than 15 years and has published over 40 scientific papers. Since 2018, she is member of the Austrian Standards Institute, the CENTC140/WG3 ‘Quality management in medical laboratories’, ISO/TC212/WG4 ‘Microbiology and molecular diagnostics’ and ISO/TC276/WG2 ‘Biobanks and bioresources’. She contributes to the development of CEN/TS and ISO standards for ‘Molecular in vitro diagnostic examinations – Specifications for preexamination processes’ and co-coordinates the development of “ISO 20166-4 FFPE in situ detection’ and the ‘CEN/TS human specimens – microbiome DNA’. Since 2017, she is member of the H2020 project SPIDIA4P.

Andrea Wutte, MSc

Andrea M. Wutte has been leading BBMRI-ERIC‘s Quality Management Service since 2014. The service includes QM consultancy programmes for biobank- and biomedical research-relevant European and international standards and guidelines, monitoring and audit programmes, training and education formats, assessments and the initiation of improvement strategies/actions and accompanying measures. Andrea holds a European Quality Manager and Lead Auditor EOQ personnel certificate and is advisor for several accreditation agencies. She acts as BBMRI-ERIC Liaison Officer to ISO/TC 276 Biotechnology, ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems, ISO/TC 215 Health informatics and CEN/TS 140 In vitro diagnostic medical devices. She is a biologist by training, and received her university degree from the University Graz.

Karl-Friedrich Becker, Prof. Dr.

Karl-Friedrich Becker is Head of the Laboratory for Experimental Pathology and recently appointed as the Scientific Director of the tissue bank of the Medical School of the Technical University of Munich (TUM), Germany. As partner of the European large-scale project SPIDIA (www.spidia.eu) and the m4 Munich Cluster of Excellence (www.m4.de) the molecular biologist analyzed the variability of protein and phosphoprotein levels in clinical tissue specimens during the pre-analytical phase. Prof. Becker is expert and project leader of CEN/Technical Committee 140 (In-vitro Diagnostic Medical Devices) Working Group 3 and ISO/TC 212 (Clinical Laboratory Testing and In vitro Diagnostic Test Systems) Working Group 4. He is chair of the Working Group 2 in BBMRIERIC`s program on quality management aiming to harmonise CEN Standards for European biobanks. He has published more than 117 peer reviewed papers.

Daniel Groelz, PhD

Daniel Grölz is a Scientific Associate Director of Research and Development at QIAGEN in Hilden, Germany. Dr. Grölz has 23 years academia, product development, and IVD experience in the area of molecular biology.
He is the R&D project manager who led an international team within PreAnalytiX GmbH to develop the PAXgene Tissue and the PAXgene Blood ccfDNA System and to evaluate the technologies for different molecular applications and use in routine pathology workflows within European collaborative grant projects.
He is the main inventor of the PAXgene Tissue System and inventor/co-inventor of the PAXgene Blood ccfDNA stabilization chemistry.
Prior to joining QIAGEN, Dr. Grölz worked for Autoimmun Diagnostika GmbH in Albstadt, Germany. Dr. Grölz received a Ph.D. in Biology from the University of Mainz with a concentration in Physiological Chemistry.

Stefania Gelmini, PhD

Stefania Gelmini, (degree: Biological Science, PhD: Clinical Pathophysiology), is a molecular biologist employed at the Clinical Biochemistry and Clinical Molecular Biology Unit, Department of Experimental and Clinical Biomedical Sciences of the University of Florence.
Her areas of research are molecular oncology with a focus on molecular diagnostics and on cancer biomarkers and biospecimen processing for molecular analysis. As an expert in particular of pre-analytical procedures for in vitro diagnostics for blood and other body fluids, she participates to the CEN (European Committee for Standardisation) / TC140 “ In Vitro Diagnostic Medical Devices” Working Group 3: Quality management in the medical laboratory. She contributed to the development of CEN and ISO standards for pre-analytical processing of blood samples for molecular testing (DNA, RNA cell free DNA), of CEN standard on molecular in vitro diagnostic pre-examination for isolated genomic DNA from saliva and of CEN standards on Circulating Tumor Cells molecular in vitro diagnostic pre-examination for isolated DNA, RNA and staining. She participated to the FP7 SPIDIA project and she is currently involved in the H2020 SPIDIA4P project. Within the SPIDIA project, she coordinated the implementation of the EQAs for the pre-analytical phase in blood specimens for gDNA, RNA, cfDNA attended by more than 200 European laboratories. She is author of 70 peer-reviewed scientific publications.

Kalle Guenther, PhD

Kalle Günther is an internationally leading expert in the field of pre-analytical workflows from human liquid samples to isolated nucleic acids for use in In Vitro Diagnostics (IVD) and Research Use. At QIAGEN GmbH in Hilden (Germany) he is Associate Director of Research and Development and leads international product development projects of PreAnalytiX GmbH (QIAGEN/Becton Dickinson company).
Dr. Günther has 25 years of experience in academia and molecular diagnostic industry and has developed and launched several products for the collection, stabilization, transportation, storage and processing of clinical samples and the isolation of nucleic acids within QIAGEN’s world renown PreAnalytiX’s product line PAXgene. His scientific work is presented in patent applications, patents, scientific publications and abstracts.
He was responsible for execution of work packages in the pan-European FP7 SPIDIA Consortium (2008-2013) and currently works as national committee member of CEN/TC140 WG3 and ISO/TC212 WG4 in the H2020 SPIDIA4P Consortium (2017-2020) on the development of technical specifications and standards for medical laboratories. Dr. Günther received a Ph.D. in Biology from the Technical University of Aachen (Germany) with focus on molecular biology and biochemistry.

Pamela Pinzani, Assoc. Prof. PhD

Pamela Pinzani works as Associate Professor of Clinical Biochemistry at the University of Florence (Italy). She is a molecular biologist involved in cancer research with a focus on circulating tumor cells, also at the single cell level, and cell-free nucleic acids in a variety of tumors.
She worked on the application and development of immunological methods with non-isotopic tracer and on the optimization of bioluminescence and chemiluminescence assays to investigate urinary metabolites of steroid hormones and proteins and for the use of the enzyme luciferase as reporter gene. More recently, she demonstrated a special interest in molecular technologies for the optimization of real-time quantitative PCR protocols in the context of human solid tumors. Moreover, she developed methods for the measurement of tumor-related markers in cell-free plasma DNA and for the detection of circulating tumor cells (CTCs) in the peripheral blood of oncological patients.
From 2018 she is a member of the CEN European Committee for Standardization CEN/TC140 (In vitro Diagnostic Medical Devices, WG3: Quality management in the medical laboratory) and ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test system, WG4: Microbiology and molecular diagnostic) contributing to the development of CEN and ISO standards for pre-analytical processing of blood samples for molecular testing (DNA, RNA cell free DNA) and of CEN standards on Circulating Tumor Cells molecular in vitro diagnostic pre-examination for isolated DNA, RNA and staining. She was involved in the to the FP7 SPIDIA project and she is currently participating in the H2020 SPIDIA4P project.
She is author of 120 publications in International peer reviewed journals, 30 papers included in national and international books and 20 manuscripts published in national journals.


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