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

ComplianceOnline

Tuesday, February 12, 2013 from 10:00 AM to 11:30 AM (PST)

Palo Alto, CA

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

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Online Registration Ended $249.00 $14.69

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Event Details

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.

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

 

 

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Have questions about Making All Data Count: FDA Acceptance of non-US Clinical Trials? Contact ComplianceOnline

When & Where



Online Webinar
2600 E. Bayshore Road
Palo Alto, CA 94303

Tuesday, February 12, 2013 from 10:00 AM to 11:30 AM (PST)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on :

 

  • Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
  • Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
  • Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
  • Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

 

 

 

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