Adverse Event Reporting in Europe

If you conduct European clinical trials you have many questions, such as:
1) Are the rules across Europe consistent and where do I find them?
2) How are adverse events defined in Europe?
3) Do I have to report ALL adverse events?
4) Do I have to report adverse events not related to my device?
5) How do I handle unexpected adverse device effects?
6) Is noncompliance to the regulations an adverse event?
7) I have an SADE at site 1, site 2 hasn't started yet, do I have to tell them about it?

The Objective
To learn the rules for adverse event and effect reporting in Europe and to learn if Europeans really follow them.

The e-Conference
Esteemed trainer Janette Benaddi will discuss where to find the rules for reporting adverse events and effects in Europe, how they differ from one country to another, and how to follow them. She will address the issues that make European AE reporting so difficult for Americans. She will also give us valuable insight into what European sponsors really do.

You will receive
Answers to your questions.
Direction for future actions.
PowerPoint slides.
An experienced speaker.
Case studies and examples.
CEUs and certificate of attendance.

The presenter
Janette Benaddi is CEO of Medvance Ltd; which provides clinical research and regulatory consulting services to medical device, pharmaceutical and healthcare industries. Ms. Benaddi can be reached at janette@medvance.co.uk.

Audience suitability
 [x] Regulatory professionals.
 [x] Clinical research professionals whose trials will be used to support 510(k)s.
 [x] Managers who sign off on clinical device trials.
 [x] Managers who sign off on regulatory submissions.
 [x] Executives who are planning their companies futures.

The purchase is $424for OnDemand access and $474 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.