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Tuesday, June 25 • 10:30am - 11:30am
#232: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-606-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Linda B. Sullivan, MBA

Speaker

Panelist
Sherry Merrifield

Panelist
Ann McCabe

Panelist
Suzanne Lukac



Speakers
avatar for Suzanne Lukac

Suzanne Lukac

Senior Account Director, CluePoints
Suzanne has nearly 20 years experience in the pharmaceutical industry including hands-on experience with RBM implementation. She is currently Senior Account Director at CluePoints where she is responsible for managing enterprise-level accounts and working with customers to lay the... Read More →
avatar for Ann McCabe

Ann McCabe

Director, Process Excellence and Risk Management, Daiichi Sankyo Inc
Ann E. McCabe Director, Process Excellence & Risk Management Ann McCabe is Director, Process Excellence & Risk Management at Daiichi Sankyo. She has worked in clinical research for over 20 years at various global pharma, biotech, medical device and consulting companies. She has worked... Read More →
avatar for Sherry Merrifield

Sherry Merrifield

Senior Director, Global Operations Management, Syneos Health
Sherry Merrifield has over 20 years of clinical operations experience. In her current role she is Senior Director of the Global Operations Management group focused on the optimization of Syneos Health’s data-driven RBM solution and application of ICH E6 R2. Her experience in this... Read More →
avatar for Linda Sullivan

Linda Sullivan

Executive Director, Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 11A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA