ComplianceOnline, Online Webinar
2012-06-12
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. 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.
|
|
|
Invited Speakers:
|
|
Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA.
|
|