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For the second episode of this webinar series, we will cover the clinical evidences required for all in vitro diagnostics devices to enter the European market under the new In Vitro Diagnostic Regulation EU 2017/746.
Clinical evidences include scientific validity, analytical performance and clinical performance of the device, this webinar will discuss the amount and type of data that could be used to demonstrate compliance to the regulation, for general IVD devices, but also self-test and near patient testing. In addition, we will also discuss requirements of the post-market surveillance program (PMPF) and the impact on clinical evidences and maintenance of conformity of devices after entering the market.
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