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
After issuance of the guidance document ICH Q9 - Quality Risk Management in 2006, there was an expectation that every discipline within the pharmaceutical industry
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment. This balance requires a risk-based approach at the system and project level.
Let's talk about how DDi can help you