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What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?

 
  September 21, 2016  
     
 
Xtalks Life Science Webinars, Online
2016-10-05


With the aim of improving efficiencies in trial conduct while ensuring participant safety, regulatory guidelines have recently undergone revision. The revision to the ICH Guideline for Good Clinical Practice (E6 R2) primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. With the pending adoption of these revised guidelines, it’s time to evaluate how your organizational structure and processes will be affected.

Research Word ArtKey discussion points:

  • The changes to the guideline, particularly regarding how they affect quality management and risk-based monitoring
  • Suggestions for interpreting the guidelines and how they specifically affect your organization
  • Considerations when implementing the guidelines
 
 
Organized by: Xtalks Life Science Webinars
Invited Speakers: Kristin Mauri, MBA, Senior Director, Global Consulting, eHealth Solutions, Bioclinica
 
Deadline for Abstracts: 2016-10-05
 
Registration: https://attendee.gotowebinar.com/register/8722133649767236098
 
   
 
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