FDAnews Announces -- Implementing the IMDRF Codes: Essential Adverse Event Reporting Changes Webinar Aug. 20, 2020
FALLS CHURCH, Va., Aug. 11, 2020 /PRNewswire-PRWeb/ -- Implementing the IMDRF Codes: Essential Adverse Event Reporting Changes An FDAnews Webinar Thursday, Aug. 20, 2020, 1:30 p.m.-3:00 p.m. EDT https://www.fdanews.com/imdrfcodes
Beginning September 7, the FDA will require devicemakers to use a new coding system and form for adverse event reporting. The EU made change back in January 2020.
The FDA and the EU Notified Bodies expect manufacturers to implement changes to their reporting using new forms as part of the vigilance process.
Dan O'Leary, President of Ombu Enterprises, is presenting an online event to explain what one must know and do to stay compliant, including:
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)
A description of the IMDRF codes used in the EU's MIR
Join us to master the new directives put in place for adverse event reporting. Understand the new coding system and stay compliant.
Interested in registering multiple sites? Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount
Webinar Details: Implementing the IMDRF Codes: Essential Adverse Event Reporting Changes An FDAnews Webinar Thursday, Aug. 20, 2020, 1:30 p.m.-3:00 p.m. EDT https://www.fdanews.com/imdrfcodes
About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations
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