- Introduction (00:01:37)
- Definitions (00:01:25)
- Obligations (00:03:47)
- MDCG and Reporting (00:01:24)
- MDD vs MDR (00:03:25)
- Conclusion (00:00:42)
MDR ADVERSE EVENT REPORTING IN CLINICAL INVESTIGATIONS
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.
Why take this course
This Meditrial Video Course By Monique Latourette is designed to help you understand the new provisions for adverse event recording and reporting to the authorities within the scope of clinical investigations under the new MDR.
What I will learn
This course will highlight the MDR provisions on adverse event recording and reporting as well as MDR definitions for safety reporting regarding adverse events and relevant Sponsor obligations.
Skills I will gain
- Explore relevant MDR definitions regarding adverse events
- Understand the different Sponsor obligations in case of adverse events occurring during the clinical investigation
- Final Test – MDR Adverse Event Reporting in Clinical Investigations
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