Subject: FDAnews Announces — Adverse Event Reporting: A Tale of Two Systems Webinar Dec. 17, 2020

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Reporting an adverse event for a device marketed in the U.S. and EU isn’t simple but this webinar has the framework one needs. Register today.



Adverse Event Reporting:
A Tale of Two Systems
An FDAnews Webinar
Thursday, Dec. 17, 2020, 1:30 p.m.-3:00 p.m. EST

Reporting an adverse event in the U.S.? If a device is being marketed in the EU, one must report it there as well. And there are different requirements in the two regions making the task even more complicated.

During this Adverse Event Reporting: A Tale of Two Systems webinar on Dec. 17, attendees will find ways to make the process more straightforward. Through Ombu Enterprise’s regulatory reporting paradigm, one will learn the similarities and differences between the two systems when it comes to triggers, timing, content, transmission, retention, custodian and access. Get practical insights into the process and discover what methods a team should use to ensure compliance.

Dan O’Leary, President of Ombu Enterprises, will demonstrate these procedures with a hypothetical event that would be reportable in the U.S. and the EU. One will move through both forms with a side-by-side analysis of the obligations and steps, gaining the insights needed to complete a successful reporting document.

During this webinar, attendees will cover:

  • Key requirements in adverse event reporting to regulators in the U.S. and the EU
  • Important differences between reporting systems in both regions
  • Recent changes in the adverse event reporting forms in the U.S. and the EU
  • Comparisons of the content expectations in the forms for both systems
  • The details of a report, including what triggers it, how much time a manufacturer has to report, what is included on the forms, how to share this information with a regulator, how long the report should be kept, who is responsible for reporting and who has access to the report

Adverse event reporting is never a simple process but having to do it in two places makes it twice as complicated. Join this webinar and get the knowledge you need to more smoothly and appropriately report an event in both the U.S. and the EU.

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:
Adverse Event Reporting:
A Tale of Two Systems
An FDAnews Webinar
Thursday, Dec. 17, 2020, 1:30 p.m.-3:00 p.m. EST

$287 per site

Easy Ways to Register:
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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Michelle Butler
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