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The monitoring process according to upcoming ICH E6 (R2) is now becoming systematic, prioritized and risk-based. This is defined by the (Food and Drug Administration) FDA and (European Medicines Agency) EMA guidelines concerning quality by design, risk management and risk-based monitoring (RBM ).
With the FDA and EMA Risk-Based Monitoring (RBM) guidances as well as the upcoming ICH E6 (R2) changes, are you ready for RBM? This webinar will help you assess whether your organization is ready for RBM as well as discuss steps to take to implement RBM. During this webinar you will:
Gain an understanding of RBM in the more general context of Quality Risk Management
Understand the various tools and concepts of RBM
Learn about the foundation for building a Risk Management framework
Understand the steps needed to implement RBM in a Risk Management framework
Date/ Time: May 25th @ 11am EST
Speaker:
Angie Maurer
RN, BSN, MBA, CCRA
Owner/Principal, Maurer Consulting, LLC
Click here to register : http://www.ddismart.com/registration-for-are-you-ready-for-rbm-process-and-technology-wise
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