A World Apart Understanding Differences in EU and U.S. Drug and Device Adverse Event Reporting
Product Details
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.
Clear your calendar for Wed., May 30, when you’ll hear from top experts in an intensive “virtual conference,” A World Apart: Understanding Differences in EU and U.S. Drug and Device Adverse Event Reporting
A Day of Learning
It’s a Virtual Conference, 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
A World Apart: Understanding Differences in EU and U.S. Drug and Device Adverse Event Reporting is convenient to attend. All that’s required is that your team be in front of a screen at the appointed time.
Here’s How It Works
Twenty-four hours prior to Virtual Conference Wednesday, attendees will receive all presentations.
Then just log on to the Virtual Conference website and dial a toll-free number, both provided in your registration confirmation. And relax. That’s all there is to it.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
Don’t take unnecessary risks. Sign up today for this timely learning event.
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Stress-free! No airport security hassles, no 4 a.m. wakeups, no anonymous hotel rooms. You never even leave your building — not even your own desk.
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Interactive! Constant opportunities to ask questions and get involved. Send in queries via e-mail ... you’ll have answers before you log off.
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Up-to-the-minute! Every speaker operates in the real world, in real time. If news breaks on Virtual Conference morning, you’ll hear about it before the session ends.
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Great value! Spread the word! There’s no limit on number of attendees per site. One low registration fee covers them all. Or register three or more locations for deeper discounts still. Get details here