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MDR STUDY APPLICATION AND APPROVAL – NEW COORDINATED ASSESSMENT

$179.00

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.

Description

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

 

TOPICS

  • 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)

  • Final Test – MDR Study Application and Approval
  • Certification

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