MDR Adverse Event Reporting in Clinical Investigations

$179.00

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.

  • Course Type: Video Lessons
  • Language: English
  • Level: Intermediate
  • Session: year 2021
  • Time: 0 - 1 Hour
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Course Breakdown

Section Time
MONITORING FOR MEDICAL DEVICES IN THE US 00:05:00

Exam and Certifications

  • Final Test – Monitoring for Medical Devices in the US Essential FDA Guidelines
  • Certification

Description

What I will learn?

The digitization in healthcare. This includes the role of electronic clinical trial data and electronic source documents to enhance clinical trial conduct and data integrity using risk based approach guidance’s.

Skills I will gain

  • Digitization Across Healthcare
  • Risk Based Approach To Monitoring
  • COVID-19 And Clinical Trials
  • FDA Guidance for Industry

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