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Learn the new definitions and types of trials contained in the MDR, understand when investigations are not required and much more. -
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! -
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. -
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 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). -
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 recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the fundamental concepts of global quality for medical devices and clinical trials. She brings to you her professional perspective which stems from her extensive background as an FDA inspector. -
Get Certified Today!
Do you need an MPG certificate to carry out clinical trials with medical devices? Would you like to deepen your knowledge? This Mastertrial MPG/GCP course is all online and is recognized by the Berlin Medical Association (CME). This Basic Course offers the following accredited training course for principal examiners, examiners and members of the examination group. Download the MPG courses brochure
Clinical Trials in Europe and the US
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