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
If you have conducted non-IND clinical trials at non-US locations or if you would like to understand how non-IND trials can be used successfully to support an IND/IDE or a marketing approval application, this seminar is a must for you. The speaker will share his extensive experience in multi-national IND and non-IND studies to underscore the critical issues that need to be addressed when using non-US data for discussions with FDA. Case studies from drugs, biologics, diagnostic kits and medical devices will be used to highlight product specific issues with non-US clinical trials.
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
For Registration:http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702281?channel=Eventsbot
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