Industry: Healthcare

Essential Adverse Event Reporting Changes Webinar Aug. 20, 2020

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (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

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/imdrfcodes

By phone: 888.838.5578 or 703.538.7600

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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