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  • This lecture investigates the new Medical Device Regulation (MDR) with regard to conditions, ethical principles, methods and informed consent process. The intent of this tutorial is to describe the conditions for carrying out clinical investigations and to outline the rules laid down by MDR for particular clinical investigation types.
  • This course presents an overview of the "actors" within the scope of the new MDR, namely the sponsors, investigators, and subjects. Learn all you need to know about how these "actors" play a significant role within the new MDR. After the course, you can take a brief test to receive your certification. Enjoy!
  • Learn the new definitions and types of trials contained in the MDR, understand when investigations are not required and much more.
  • NEW REQUIREMENTS FOR SAFETY REPORTING DURING CLINICAL INVESTIGATIONS This course highlights new safety reporting obligations introduced by the Medical Device Regulation.
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  • Viaggio nel mondo delle Tecnologie Medicali e Digital Health.
    L’Università degli Studi di Roma Tre e Meditrial presentano una giornata dedicata al mondo dei Medical Device all’interno del Master Sociosanitario. Le testimonianze di esperti, protagonisti nel settore sanitario, socio-sanitario e socio-educativo, racconteranno l’evoluzione del panorama globale in ambito MDR a livello clinico e regolatorio.
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  • This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time!
  • Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.
  • In this course, you will learn all the important information about the CTIS, its timelines and user roles. You’ll also discover what training materials are available at European Medicines Agency website.
  • Pharmacovigilance is required through the entire life cycle of a drug – starting from preclinical development stage, going through continues monitoring till regulatory approval as well as spanning post-market stidues. Discover with Meditrial all aspects of European Pharmacovigilance and Drug Safety that include collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies. Upon completing a course, you will take a final test to receive a digital certificate that can be printed.
  • Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders.

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