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LIVE WEBINAR -"Implementing the IMDRF Codes: Essential Adverse Event Reporting Changes"
1:00 PM - 2:30 AM New York
Date: August 18, 2021 to August 19, 2021
Where: New York, New York,, New York County, New York, United States, 10000
Phone: N/A
Event Type: Other
Ticket Price: N/A
Beginning September 7, the FDA will require device makers to use a new coding system and form for adverse event reporting. This most recent coding system was developed to improve, harmonize and expand the terminology and systems being used to code information relating to adverse events. Join us on August 20 to understand the new IMDRF codes and prepare for your Medical Device Reports (MDR). The FDA is not alone in making changes to its MDR form. The EU implemented a new mandatory MIR form this past January. EU Notified Bodies expect manufacturers to have already implemented the new form as part of the vigilance process.Our speaker will present on what you must know and do today and before your September 7 deadline. Webinar Takeaways: An introduction to the IMDRF code sets An explanation of the code set structures The planned changes to FDA’s reporting form The relationship between the IMDRF codes and the current FDA codes An explanation of the EU Manufacturer’s Incident Report (MIR)
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