A World Apart Understanding Differences in E.U. and U.S. Medical Device Adverse Event Reporting

Held April 12, 2011

The FDA recently estimated that more than 10,000 adverse event reports for medical devices are submitted annually in the U.S., with an even higher number reported in the E.U. 

Failure to understand adverse event reporting in either the U.S. or the E.U. can result in faulty clinical trials and warning letters.

Make an important decision today. Learn how to bulletproof your adverse event reporting protocols by attending this upcoming webinar.

Device manufacturers: Here’s a test of your basic knowledge.

  1. In the U.S., electronic reporting of adverse events is optional. In E.U. nations, electronic reporting is:
    • Optional
    • Mandatory
    • Don’t know
  1. The EU rules for reporting adverse events that result from user error or off-label use of a device are:
    • Same as the FDA’s
    • Different from FDA’s
    • Don’t know

Put down your pencil ... but don’t relax. The real-life stakes are high — much, much higher than in a pop quiz.

If you market medical devices in E.U. countries — and who doesn’t? — you need to know E.U. regulations as thoroughly as you understand FDA regulations.

Bet you don’t, though. So here’s how to get a running start.

Mark your calendar for Tuesday, April 12, when FDAnews presents A World Apart: Understanding Differences in E.U. and U.S. Medical Device Adverse Event Reporting.

Two experienced lawyers — one in Washington, Steven Datlof, MD, JD, the other in Brussels, Elisabethann Wright, BL — will lead the session and spell out where and how FDA and EMA rules differ ... and where they’re similar.

In just 90 minutes, you’ll discover key areas of compliance, as well as penalties for failing to observe them. You’ll learn:

  • Specifics of the European Medical Devices Vigilance System and FDA’s MDR rules, 21 CFR Part 803
  • Similarities and differences in incident reporting under the E.U. and U.S. systems
  • How to perfect your reporting procedures to work under both U.S. and E.U. rules
  • The most common EMA reporting errors and how to avoid them
  • Consequences of not meeting your reporting obligations under each system, and risks of under-reporting and over-reporting
  • How to ensure patient safety and avoid the penalties of noncompliance
  • And much more

A World Apart: Understanding Differences in E.U. and U.S. Medical Device Adverse Event Reporting is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.

Of course, Mr. Datlof and Ms. Wright will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.

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.

FDA warning letters and 483s are bad enough without EMA sanctions too. Why take the risk? Start learning what you need to know. Order now for this bi-continental regulatory boot camp.

The list of those who will benefit from this webinar is a long one, including (but not limited to):

  • Medical Directors
  • Study Directors
  • Compliance officers
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Training personnel
  • Academic researchers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Steven Datlof, MD, JD, is a partner in the Philadelphia office of Hogan Lovells. His practice focuses on FDA regulation of medical devices, pharmaceuticals and biologicals. He works with companies to develop regulatory strategies for obtaining FDA marketing approval for their products and represents them before the agency. A physician as well as a lawyer, Mr. Datlof focuses on counseling related to the intersection of regulatory, legal, and clinical issues.

Elisabethann Wright, BL, is a partner in the Brussels office of Hogan Lovells International.  Her experience in European law includes both private practice and work with international institutions. She focuses on European Union (E.U.) law relating to life sciences, emphasizing pharmaceutical law, medical devices, food law, and the environment.

Order now!