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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. -
This course describes key principles of general safety and performance requirements. In this video we will discuss in detail article 56 of IVDR and will give practical advices on how to plan and prepare for the IVDR. Finically, we will explain what is the performance evaluation and which periodic deliverables and when need to be updated accordingly. -
This lecture presents the new European regulation for medical devices and provides an easy to learn overview of all the key changes. Learn all you need to know for a successful transition to the new legislative framework. -
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. -
Il mondo della ricerca clinica sui Medical Device sta subendo in questi anni una forte evoluzione dovuta all'incremento degli standard di qualità che in tempi brevissimi dovranno raggiungere il livello delle sperimentazioni con farmaco. Per questo motivo è fondamentale per chi lavora in questo ambito, ma anche per chi vuole ampliare le proprie prospettive, conoscere quali saranno gli scenari futuri dovuti a questa rivoluzione.
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
