Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the U (Clinical Compliance)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jun 12, 2012 End Date/Time: Jun 12, 2012
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This webinar will cover essential elements of multi-national medical device clinical trials, help you understand US and non-US regulatory processes for medical device clinical trials and provide practical tips for assuring US market approval for your device.

Why Should You Attend:

Testing of medical devices raise unique regulatory, logistical and practical issues that need to addressed for successful completion of a given trial. The biggest challenge perhaps is conducting multi-national trials with medical devices primarily because medical devices are developed and regulated very differently in the US compared to the rest of the World. This session will discuss all these issues and challenges - including the use of controls or shams, IRB review of medical device trials, patient access, informed consent issues, retrospective clinical experience data, patient access to dual-availability devices, personnel training, charging a participant for the cost of an investigational medical device, and GCP compliance -using case studies from the presenter’s extensive experience with conducting multi-national medical device clinical trials.


Online Event
2600 E. Bayshore Road
Palo Alto
United States