The scientific program of the congress covers QUALITY IN LABORATORY and DEVELOPING HEALTH TECHNOLOGY.
QUALITY IN LABORATORY:
The usefulness of measurement uncertainty | From Analytical to Diagnostic Quality: Approaches to Interpretative EQA | Green and Sustainable Laboratories
DEVELOPING HEALTH TECHNOLOGY:
Compliance | Future of MedTech | Sustainability
Chair of the Finnish Climate Change Panel
Markku Ollikainen will open the congress by discussing sustainable development and how laboratories can be more ecological.
PhD, MBA in Safety Management
In the closing lecture, award-winning author and speaker Harri Gustafsberg will be discussing how to prepare for challenging situations in the future.
QUALITY IN LABORATORY
MD, PhD, Clinical Consultant in Medical Biochemistry
Fürst medisinsk laboratorium
MD, PhD and Clinical Consultant in Medical Biochemistry with a broad experience of everyday practice in Laboratory Medicine. Current research interests: Quality control, digital communication, mathematical models in medicine, databases, machine learning and cancer epidemiology. Bjerner has performed technical assessments since 2006 in Norway and Sweden, mainly for medical laboratories.
PhD, professor of clinical epidemiology
Amsterdam University Medical Centers
Patrick M. Bossuyt is a professor of Clinical Epidemiology at the Amsterdam University Medical Centers, where he leads the Biomarker and Test Evaluation research program. The BiTE program aims to appraise and develop methods for evaluating medical tests and biomarkers, with an emphasis on clinical performance, and to apply these methods in relevant clinical studies. Dr Bossuyt spearheaded the STARD initiative for the improved reporting of diagnostic test accuracy studies.
Head of Certification IVD
Marta Carnielli works for TUV SUD as Head of Certification IVD; in this role, she is responsible for the certification process for IVD medical devices as well as ensuring accreditations, designation and authorization relevant to IVDs are maintained by TUV Sud. She is representing TÜV SÜD in regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements. She was the Co-Chair of the IVD Notified Bodies Working Group Prior to joining TÜV SÜD,
Reagent Labeling & Test Setting Team Leader
Morgane Clara joined Stago in 2010 and has been a part of the Labeling Department since 2011. She has experience in IVD labelling regulation and has since contributed to the implementation of the digitalization of IFUs at Stago.
Acibadem Mehmet Ali Aydinlar University
Senior Inspector at Finnish Medicines Agency Fimea
Senior Inspector in the supervision of in vitro diagnostic (IVD) medical devices at Fimea. Its remit includes providing guidance and advice to those involved in the sector, market surveillance, incident handling and cooperation at EU level to promote uniform, well-functioning European equipment legislation. Prior to joining the authority, Nelli has worked e.g. in IVD and bioscience companies in research and development and in the university world investigating the packaging mechanisms and evolution of viral genomes.
Piet Meijer is the director of the ECAT Foundation, a non-profit global provider of external quality control in the field of thrombosis and haemostasis. He is a member of several national and international societies in the field of thrombosis and haemostasis and external quality assessment. He is an expert member of the EQALM/EFLM Post-Analytical Working Group. He chairs the ICSH (International Committee of Standardization in Haematology) guideline group on Factor VIII and IX inhibitors. He is the International advisor for the ProMeQuaLab project (quality improvement in medical laboratories in Portuguese-speaking developing countries). He is a member of the IFCC Working Group on PT/INR Standardization.
President of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
EuSpLM, PhD, D.Sc., and Specialist in Clinical Biochemistry, Prof Ozben is the current President of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). She has been the Chair or Member of many Federations, Scientific Organizations, Societies, Committees and Councils. She is the Past-IFCC Treasurer, Past-Chair of the IFCC Congress and Conference Committee, Past-President of the Balkan Clinical Laboratory Federation (BCLF), and one of the Board of Directors of the IFCC Foundation for Emerging Nations (FEN). Additionally, she has recently been chosen as the president-elect of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).
Professor Sverre Sandberg is the director of the Norwegian Quality Improvement of Laboratory examinations (NOKLUS) and the Norwegian Porphyria Center (NAPOS). He has been chair of the Committee on Evidence-Based Laboratory Medicine in IFCC, president of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM), president of the European Federation of Clinical chemistry and Laboratory Medicine, EFLM and board member of IFCC. He is currently the president of the European Porphyria Network Association (EPNET) and chair of the council of International cooperation for harmonisation of clinical laboratory results (ICHCLR). He is chair of the EFLM TG of the biological variation database.
MBBS, FRCP(C), MSc. Associate Professor, Department of Laboratory Medicine and Medicine
University of Toronto
Dr Rita Selby is a haematologist specialising in thrombosis and hemostasis, and the medical director for two regional reference coagulation laboratories at both the University Health Network and Sunnybrook Health Sciences Centre, two quaternary care academic teaching hospitals fully affiliated with the University of Toronto. She is an Associate Professor in the departments of Laboratory Medicine & Medicine at the University of Toronto. Her research interests include coagulation laboratory quality assurance, appropriate utilization of laboratory testing and pragmatic clinical trials in anticoagulation and thromboembolism.
DEVELOPING HEALTH TECHNOLOGY
Development manager, Masters in Soc. Sciences
Riikka Juuma works as a development manager at Hansel (Central Procurement Company) consulting public organizations in procurement leadership and sustainability. She is an enthusiastic expert on sustainable public procurement. She has previously worked for several years at HUS (Helsinki University Hospital) developing sustainable procurement practices in the healthcare sector.
Toni Kajantola has been focusing on digital services and device testing for the last 20 years. In his current role as a HUS IT Test manager, he is responsible for testing processes, partnerships and frame agreements.
Triolab Oy I Triolab Baltic OÜ
Managing Director of Triolab Oy covering Finland and Triolab Baltic OÜ covering Estonia, Latvia and Lithuania. Triolab Group is one of the leading distributors of medical devices in the Nordic and Baltic countries. Jussi has over 25 years of experience in the medical devices industry both in manufacturing and distribution.
Dr Ilpo Kuronen has a long history of management of the MD and IVD companies. He has worked in various executive roles in R&D, quality assurance and business development. Currently, he works as a CTO in Reagena Ltd and is responsible for technology and business development.
Kustannus Oy Duodecim
Minna Makki has in cooperation with Healthtech Finland member companies conducted research on the status of sustainability of medical device manufacturers based in Finland. She has worked as a Customer Experience and Quality Lead at a small medical device manufacturer. Her hands-on experience includes implementing a quality management system, and reaching and managing medical device manufacturer compliance with EU and Brazilian Health Regulatory Agency Anvisa’s requirements. Her prior versatile background includes multi-disciplinary leadership and business roles at innovative technology companies.
PhD, Clinical Study Manager
Jari Martelin has two decades of experience in clinical microbiology diagnostics and has been actively involved in developing and testing of various In Vitro Diagnostic (IVD) microbiology methods for diagnostic use. In the early years, he worked as a clinical microbiologist in clinical microbiology laboratories and was responsible particularly for the implementation and verification of molecular diagnostic methods and devices in routine use. Currently, he is working as a clinical study manager at Uniogen being responsible for the performance evaluation of newly developing assay products and their post-market surveillance studies.
MBA, CEO of Oy Reagena Ltd since 2017. Before Reagena, she has worked within IVD and biotechnology industry in various management positions.
Miia Salonen has worked at GS1 for over 10 years and is a specialist in the benefits of the GS1 system. Her role as Development Manager is to support UDI compliance and drive the use of global GS1 standards in the healthcare sector. Her special interest is in bringing the standards to life, i.e. finding valuable use cases and benefits for industry and healthcare providers.
MSc, Director, Operations
Director in Radiometer Turku Oy leading Operations. Extensive experience in R&D and Operations for Medical Devices, especially in the Diagnostic field.
Under the auspices of