Originally aired 07 April 2021
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There is no question that the European In Vitro Diagnostic Regulation (IVDR) is complex and will have far-reaching implications. How ready is your business for the implementation of the new regulations? Do you know what the role of your organisation is as defined by IVDR? Understanding and analysing your product portfolio will highlight what you need to discuss with suppliers and subcontractors to ensure you develop a robust supply chain to maintain continuity.
Our last webinar, ‘Getting ready for IVDR’, helped equip you with information to draw up an action plan. In this webinar, our panel of experts will discuss the commercial considerations in more detail. We’ll examine the new responsibilities of Economic Operators, whether your product is an IVD according to IVDR classification and explore the Research Use Only vs General Lab use in relation to IVDs.
Head of In Vitro Diagnostics & Principal Consultant, Qserve Group
Sue leads Qserve’s IVD service and has over 30 years’ experience in the Medical Device and IVD industries including extensive notified body experience. She has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing and quality assurance. Sue worked for 3 notified bodies establishing two from scratch. Sue chaired the European IVD Notified Body Working Group coordinating the notified body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years. She is an experienced trainer on a variety of IVD topics.
Founding partner, Axon Lawyers
Erik Vollebregt, LLM, is a founding partner of the life sciences niche firm Axon Lawyers in Amsterdam. He has more than 20 years of legal and regulatory experience in the EU and Dutch national life sciences regulation. He specialises in regulatory and legal advice, contracts, mergers and acquisition work, and litigation in the life sciences sector. Erik is an active contributor to development of EU and Dutch law in the life sciences field through national and international trade associations and advisory committees. He has degrees in Dutch law from Groningen (Netherlands) University and in European law from Stockholm (Sweden) University.
Global Director – IVD Focus Team, TÜV SÜD
Dr Julien Senac is currently Global Director of the IVD Focus Team at TÜV SÜD, overlooking the development of IVD field and in particular IVDR. Prior to this, he has many years of experience with a certification body, where he participated in the preparation of IVDR designation, and performed Design Dossier assessment of in vitro diagnostic devices. Dr Senac has a PhD in Molecular and Human Genetics from Baylor College of Medicine (Houston, TX) and more than 10 years of experience in biomedical research. He worked in top research/medical institutions in the United States such as Mayo Clinic and the National Institutes of Health. Dr Senac has also participated to the development of multiple biotech start-up companies in oncology and gene therapy.