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For the third episode of this webinar series, we discuss requirements to economic operators introduced by the European In Vitro Regulation EU 2017/746.
Economic operators in the context of the regulation include manufacturers, authorized representatives, importers, and distributors. In this webinar, we will be discussing the requirement for each of those operators but also the responsibilities toward each other. We will discuss the increasing responsibilities and liabilities taken by authorized representative in the compliance of the product, the new reporting and controlling activities assigned to importers and distributors. The role of all economic operators will change with the new regulation and this webinar will help the manufacturer to identify the new relationship to build with each of them and smoothly prepare the transition to EU IVDR.
Dr. Julien Senac
Global Director of IVD Focus Team, TÜV SÜD
Dr. Julien Senac is currently Global Director of the IVD Focus Team at TÜV SÜD. Before 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 Ph.D. 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 in the development of multiple biotech start-up companies in oncology, gene therapy, and AIDs technologies.
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Bosnia and Herzegovina