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


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Who should attend?

Senior professionals from phama and biotech companies interested in learning more about the ICH e6 R2 revisions and the impact it will have on their organizations – Directors of Data Management Directors of Clinical Operations Study Managers Project Managers Central Monitors

Details

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.

Key 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

Contact

Dian Razak
drazak@xtalks.com

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