E. Stewart Geary, MD

Global Safety Officer,  Eisai

Topic: CIOMS XII- A New Era for Structured Benefit Risk Assessments

This presentation will describe some key concepts in the report, including:

• The current landscape for benefit-risk assessments
• The importance of using a structured benefit-risk framework
• The CIOMS XII Structured Benefit Risk Framework
• The new concepts of Key Benefits and Key Risks which are compared in the benefit-risk framework
• Evaluating benefits and risks from the perspective of the clinical trial subject using Desirability of Outcome Ranking (DOOR)

Ken Kubota

Senior Vice President PV Operations, Astellas

Jens Nordahl

Senior Project Manager, GPS Projects and Partnering, Lundbeck