A World Apart Understanding Differences in EU and U.S. Drug and Device Adverse Event Reporting
Product Details
From Brussels to Boston, Be Prepared or Risk Your U.S. and EU Sales…
When you're dealing with the European Union and the U.S. — markets that each spend in excess of hundreds of billions per year on drugs, biologics and medical devices — you want to be certain that you're well-armed in their differing adverse event reporting (AER) regulations.
Failure to understand the many differences between the U.S. and EU regulations can lead to delays in approval, repeat paperwork, additional costs or worse, outright denial of market access.
Here’s how to overcome this latest FDA compliance challenge.
The adverse event reporting requirements for drugs, biologics and medical devices in the U.S. and the EU are riddled with confusing scenarios. It’s true that the rules attempt to accomplish the same goals, but the details offer huge potential for mistakes.
For example:
- If a user or patient discovers a deficiency in a drug or device prior to use, does it have to be reported in the EU? How about the U.S.?
- In the EU, do you need to report adverse events to the competent authority where the event occurred, where the drug or device was made, or both?
- If an adverse event takes place involving a drug or medical device made in the U.S., but the device is not available for sale in the U.S., must it be reported to the FDA?
If you don’t know all the answers, you’re not alone.
A Day of Learning
It’s an audio CD/transcript sponsored by FDAnews and featuring top experts who have been in the AER trenches. Without ever leaving the comfort of your office, you’ll gain practical knowledge that helps you assure you’re in full compliance.
For drug, device, biologics and diagnostics firms that deal with EU regulators, this session couldn’t be timelier.
In just one fast-paced day, you’ll be taught how to isolate the important differences in U.S. and EU regulations. And you’ll learn strategies for effectively navigating both systems.
Here’s just a sampling of what will be covered:
- A plain-English overview and explanation of the EU and U.S. approaches
- Who must report adverse events
- Who receives adverse event reports
- Timelines for reporting
- Common events that do not need reporting in the U.S., EU or both
- Practical considerations for implementing compliant MDR and EU vigilance systems
- EU guidelines and FDA guidances that are essential to understanding reporting obligations
Key people throughout your company will benefit from listening to this audio CD/transcript. Best of all, everyone can do so at a cost that won’t break the budget.