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

Key Topics

• Comparison of US and non-US regulatory processes for medical device clinical trials
• Essential elements of medical device clinical trials: Device, protocol, sites, data
• Clinical trials with devices approved in other countries
• Concerns with non-US clinical data
• Using non-US clinical experience: retrospective data analysis
• Managing US-based and international clinical investigators

Who should Attend

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