2012 - Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the US

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.
Areas Covered in the Seminar:
This seminar will provide easy-to-master techniques to prepare perfect SOPs. Topics covered include
- Essential elements of medical device clinical trials: Device, protocol, sites, data.
- Comparison of US and non-US regulatory processes for medical device clinical trials.
- Concerns with non-US clinical data.
- Clinical trials with devices approved in other countries.
- Managing US-based and international clinical investigators.
- Using non-US clinical experience: retrospective data analysis.