Practical Issues with Conducting Multi-National Clinical Trials for Medical Device Approval in the U (Clinical Compliance)
Venue: Online Event
|Event Date/Time: Jun 12, 2012||End Date/Time: Jun 12, 2012|
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 presenterâ€™s extensive experience with conducting multi-national medical device clinical trials.