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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.
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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!
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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. -
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!
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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.