With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to ensure appropriate consideration of risk in study design and management.
For this webinar, CluePoints is again teaming up with Paragon Solutions, to highlight the key changes in the mandate and explain how best to address these elements for successful Risk-Based Monitoring Implementation.
Expect to Learn:
- Understanding the key ICH E6 updates related to Risk-Based Monitoring/Data Quality Oversight and their purpose
- Understanding how Central Statistical Monitoring(CSM) and Key Risk Indicators(KRIs) will work for you
- Critical-to-success methods for Central Statistical Monitoring and KRIs
- Change Management – Using E6 R2 to support your organization’s transition to RBM
- The Monitoring plan – not just for monitoring intervals anymore
Tuesday, March 14th, 2017, 3:00pm GMT/ 11:00am EDT/ 08:00am PDT (Timing reflects daylight savings time)