TORONTO, ON--(Marketwired - September 19, 2016) - During a live presentation on October 5, 2016 at 11am EDT (4pm BST/UK), industry expert Kristin Mauri, Senior Director of Global Consulting, eHealth Solutions at Bioclinica, will outline the changes to the ICH Guideline for Good Clinical Practice (E6 R2), with a focus on how this will affect quality management and risk-based monitoring. Mauri will also provide suggestions for interpreting the guidelines and how they specifically affect an organization and considerations when implementing the guideline itself.
With the aim of improving efficiencies in trial conduct while ensuring participant safety, regulatory guidelines have recently undergone revision. The revision 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 organizational structures and processes will be affected.
For more information or to register for this complimentary event, visit: What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?
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