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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 presentation 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.
Presentation 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 presentation.
Meet Your Presenter
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.
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