Risk-Based Monitoring & Quality Mgmt of Clinical Trials: Recent Guidance Updates from FDA & EMA

The FDA and EMA describe their expectations for risk-based approaches to quality management and monitoring in the ‘FDA Guidance Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring’ and the ‘EMA Reflection Paper on risk-based quality management in clinical trials,’ both of which are reviewed in this web seminar, which also includes industry think tank contributions.