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Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
Session Chair(s)
Linda B Sullivan, MBA
Senior Fellow
Tufts Center For the Study of Drug Development, United States
This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6 (R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring.
Learning Objective : Discuss and compare your organization’s approach with leading practices shared in the session; Describe some of the gaps in standard approaches to risk assessment and ways to overcome them; Explain the importance of metrics in risk assessment and risk control.
Speaker(s)
Panelist
Sherry Merrifield
Syneos Health, United States
Senior Director, Global Operations Management
Panelist
Ann McCabe
Daiichi Sankyo Inc, United States
Director, Process Excellence and Risk Management
Panelist
Suzanne Lukac
Synchrogenix, a Certara company, United States
Associate Principal Medical Writer