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

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Nov 19, 2013 10:00 AM
  • End Time:
  • Tuesday - Nov 19, 2013 11:30 AM
  • Location:
  • Online
  • 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.

    Why Should You Attend:
    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.

    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
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