Clinical Compliance 2012 - 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