Making All Data Count: FDA Acceptance of non-US Clinical Trials

This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA.

FDA acceptance criteria for non-IND/IDE clinical trials are based on internationally recognized standards of quality, ethics, and practices for human subject protection. An adequately designed non-US study can be used to greatly reduce the time of cost of getting the tested product to the US market.

Areas Covered:

• Comparison of US and non-US regulatory requirements for clinical trials
• Types of clinical trials with regards to product development and marketing approval
• Parameters of quality of clinical trials: investigators and sites
• Acceptable design of non-US clinical trials
• Acceptable ethical and human subject protection practices
• Acceptable data collection, analysis, monitoring, and documentation practices
• Role of IRBs, ethics committees and other regulatory bodies in clinical trial quality control
• FDA’s opinion of non-US regulatory review and approval of clinical trials
• FDA’s international clinical trial initiatives
• FDA audits of non-US clinical sites
• Best practices for using non-US human experience with products marketed outside US
• Waiver and other options for non-IND clinical trial data

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Compliance/Regulatory affairs professionals
• Clinical trial professionals
• Sponsors and investigator-sponsors of clinical trials that use non-US sites
• Project Managers for clinical trials
• Senior management for companies interested in non-US trials
• People investing in FDA-regulated product development projects