Making All Data Count: FDA Acceptance of non-US Clinical Trials
Tuesday, February 12, 2013 from 10:00 AM to 11:30 AM (PST)
Palo Alto, CA
This webinar on FDA acceptance of non-US clinical trials will discuss the current FDA requirements for using clinical data from non-IND/IDE clinical trials in support of an IND and/or marketing approval application.
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.
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.
- 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
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