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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 -
LEARN FOR FREE
Stiamo attraversando la fase 2, ma la fase 3, la fase della Consapevolezza della Nuova Normalità, sarà quella decisiva per molti aspetti, per il lavoro, l'economia, la salvaguardia della salute, la sicurezza. Inizia a farsi chiaro che sono e saranno molteplici le insidie nell'ambito della mental health che i nuovi scenari stanno già sollecitando oggi. Parleremo di come prepararci ad affrontare questa fase. -
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. -
LEARN FOR FREE What is a KOL? How to approach him? And, most importantly, how can he foster your business? This video course will provide you with insights about the world of KOLs and influencers in the Medtech and healthcare industry. Moreover, you will find out how KOLs can support the medtech development process and drive the success of your startup company!
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
