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.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

- Investigators in medical device clinical trials
- Clinical trial professionals: project managers, CRA, and site coordinators
- Clinical trial specialists
- QA/QC/Compliance/Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- People investing in FDA-regulated product development projects

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. In addition, he has had made regulatory submission in the EU and India.