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Exploring Options and Industry Implications for Regulating NGS Technologies



 
Our Price: $395.00

Product Code: WB-7129
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About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.


Next generation sequencing technologies (NGS) are revolutionizing the advancement of tests which are used to diagnose a patient’s risk for a specific disease state. These tests, however, are also proposing an especially difficult challenge for the FDA who is tasked with regulating NGS’s fluid processes and procedures. As a result of the surge in NGS development, the FDA has released a discussion paper on probable methods for demonstrating the analytical and clinical capabilities of NGS technologies and is requesting public comment. While multiple stakeholders including academia, government regulators and industry manufacturers all support future innovation within NGS tests, the need for clear and well developed regulatory framework is necessary in order for the industry to move forward in the development and application of these tests.
  • Perspective on benefits and challenges in regulating NGS
  • FDA
  • Industry manufacturers
  • Laboratory developed test
  • Analysis of Illumina’s MiSeqDx platform
  • Potential implementation timelines

Speaker:
Christine Vietz
Director of Quality Assurance
Foundation Medicine


Participants that will find this webinar most beneficial will be those involved in diagnostic companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Quality Assurance
  • Clinical Affairs
  • Legal


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