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The purpose of this tutorial is to analyze the MDR provisions for adverse events recording and reporting to Competent Authorities. The topics addressed are: MDR references, Relevant definitions, Sponsor obligations in case of adverse events occurring during the clinical investigation and Regulatory comparison: MDD vs MDR. -
This tutorial aims to provide an overview of the MDR provisions related to the end of the clinical investigation, along with an outline of the MDR rules concerning the extraordinary events which could happen during the clinical investigation (substantial modifications, corrective measures, temporary halt, early termination). -
Learn the new MDR rules for study application and approval process. The coordinated assessment procedure will streamline clinical investigations conducted in more than one EU Members State. -
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. -
LA CORRETTA GESTIONE DEGLI EVENTI AVVERSI Lo scopo di questo corso è illustrare i ruoli e le responsabilità del personale ALCON nella corretta gestione degli eventi e delle reazioni avverse. Exclusive Live Event -
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR). -
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. -
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.
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
