Adverse Event Reporting
A Tale of Two Systems


Thursday, Dec. 17, 2020 • 1:30 p.m. - 3:00 p.m. EST

When an adverse arises as the result of a medical device, that incident needs to be reported — and when the device is being marketed in the U.S. and EU, it must be reported in both. That process is never simple but having to meet different requirements in the U.S. and the EU makes it more complicated. The forms are different, the obligations are different and the procedures are different.

During this Adverse Event Reporting: A Tale of Two Systems webinar on Dec. 17, you’ll find ways to make that challenging process more straightforward. Through Ombu Enterprise’s regulatory reporting paradigm, you’ll learn the similarities and differences between the two systems when it comes to triggers, timing, content, transmission, retention, custodian and access. You’ll get practical insights into the process and discover what methods your 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. You’ll move through both forms with a side-by-side analysis of the obligations and steps, gaining the insights you need to complete a successful reporting document.

Webinar Takeaways:

  • 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. Get the knowledge you need to smoothly and appropriately report an event in both the U.S. and the EU through this webinar.

Join us by registering today.

Webinar plus Recording & Transcript Bundle
Learn more

$487

add to cart

Webinar only
Learn more

$287

add to cart

24/7 Encore plus Recording & Transcript Bundle
Learn more

$487

add to cart

24/7 Encore Presentation
Learn more

$287

add to cart

Webinar Recording & Transcript Bundle
Learn more

$287

add to cart

 

Who Will Benefit

  • Medical device manufacturers who market in the U.S. and the EU
  • Quality managers
  • Regulatory managers
  • Marketing managers
  • Compliance specialists
  • QSRs professionals
  • Inspections and audits professionals
  • Post-market safety specialists
  • Submissions and approvals staff
  • Research and development professionals
  • Commercial operations staff

 

Meet Your Presenter

Dan O’Leary

President
Ombu Enterprises, LLC

Dan O’Leary, President of Ombu Enterprises, LLC, has more than 30 years of experience in quality, operations, and program management in regulated industries, including aviation, defense, medical devices, and clinical labs. Ombu Enterprises offers training and execution in Operational Excellence and is focused on analytic skills and a systems approach to operations management. O’Leary has a master’s degree in mathematics and is an ASQ biomedical auditor, quality auditor, quality engineer and reliability engineer. He’s also a Six Sigma Black Belt and is certified by APICS in resource management.

MII logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 | Fax 703.538.7676 | Toll free 888.838.5578 | Email customerservice@fdanews.com

© 2020 FDAnews