- Introduction (00:01:57)
- Timelines & Applications (00:04:37)
- Electronic System (00:02:26)
- Coordinated Assessment (00:05:31)
- MDD vs MDR (00:02:26)
- Conclusion (00:00:46)
MDR STUDY APPLICATION AND APPROVAL – NEW COORDINATED ASSESSMENT
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.
Why take this course
This Meditrial Video Course By Monique Latourette is designed to help you explore the study application and approval process as well as the new coordinated assessment under the scope of the new MDR.
What I will learn
This course will highlight the new application process for clinical investigations through the Electronic System under the MDR and relevant timelines. You will also get to know the new coordinated assessment procedure introduced for clinical trials to be conducted in more than one EU Member State.
Skills I will gain
- Discover the novelties introduced by M-D-R, on the application for clinical investigations
- Learn the Electronic System for clinical investigations
- Understand the guidance on the new coordinated assessment procedure
- Final Test – MDR Study Application and Approval
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