New EFLM webinar: From IVD Directive to IVD Regulation

Christa COBBAERT
Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, the Netherlands

Christa Cobbaert is heading the Clinical Chemistry and Laboratory Medicine Department at the Leiden University Medical Centre (LUMC) in Leiden, the Netherlands. Her scientific research is on medical test development and evaluation, with a major focus on standardization, for the sake of better patient outcome. Her work resulted in 170 original publications and appointments on (inter)national positions because of her expertise on metrological traceability of test results. In her research group protein panels are developed using mass spectrometry-based proteomics, a promising technology for precision diagnostics and an alternative for replacing flawed and hardly standardized immunoassays. Professor Cobbaert is the current chair of the European Federation of Laboratory Medicine (EFLM) working group on Test Evaluation, which develops tools for guiding development of biomarkers to medical tests (https://www.eflm.eu/site/page/…). She is the vice-chair of the IFCC Scientific Division EC, involved with metrology and standardization of medical tests (http://www.ifcc.org/ifcc-scien…) and a member of ISO TC 212 working group 2 on reference systems. She is representing EFLM in the IVD subgroup under the Medical Device Coordination Group during meetings with the European Commission on the interpretation of the IVDR 2017/746.

Alison SMITH
University of Leeds; NIHR Leeds In Vitro Diagnostic Co-operative, Leeds, UK

Alison Smith is a Lecturer in Health Economics based at the University of Leeds, where she has worked for over 8 years. Her research focuses on the evaluation of medical tests, and the use of analytic decision modelling to inform clinical decision making. In 2020, Alison completed an NIHR Doctoral Fellowship in which she explored the role of test measurement uncertainty in health technology assessments (HTAs) for in-vitro diagnostic tests. Her special research interests include evidence-based laboratory medicine (test evaluation), economic decision modelling, early economic evaluation, and target product profile (TPP) development. Alison is a Consultant Expert member of the EFLM Working Group for Test Evaluation (WG-TE) and the EFLM Task Group: Performance Specifications Based on Outcome Studies (TG-PSOS). She is also Deputy Lead for Health Economics at the NIHR Leeds In Vitro Diagnostics Co-operative.

Phil MONAGHAN
The Christie Pathology Partnership, Manchester, UK

After graduating from the University of Manchester Institute of Science and Technology UMIST in Biochemistry with Applied Molecular Biology, Phillip Monaghan went on to complete his PhD in Molecular Enzymology at the University of Leicester. He subsequently commenced training in Clinical Biochemistry at Wirral University Teaching Hospital, Alder Hey Hospital and University Hospital of South Manchester. Phillip has been a Clinical Scientist at The Christie NHS Foundation Trust and more recently The Christie Pathology Partnership in Manchester, UK, for the past 12 years, obtaining Fellowship of the Royal College of Pathologists (FRCPath) in 2014. Phillip is Honorary Lecturer at the University of Manchester, Cancer Sciences Division within the School of Medical Sciences, and regularly teach on the MSc Clinical Sciences programme and the Advanced Therapeutics Medicinal Products programme. Phillip is Chair of the National Quality Assurance Advisory Panel for Chemical Pathology and is also Deputy Editor for the Annals of Clinical Biochemistry journal. Phillip is a Consultant Expert member of the EFLM Working Group for Test Evaluation (WG-TE). Special research interests include evidence-based laboratory medicine (test evaluation), biochemical endocrinology, and translational biomarker development. Phillip is Co-Investigator on the VALTIVE clinical trials programme for the validation of a novel vascular response biomarker to guide VEGFi therapy in ovarian cancer. Phillip was awarded the Silver Research Medal from the Royal College of Pathologists in 2012 for his work on serum cortisol measurement in Cushing’s disease.