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Session 7 – Benefit-Risk
Session Chair(s)
Stella Blackburn, MD, MA, MSC, FFPM, FISPE, FRCP
Strategy
Consultant, United Kingdom
In this session, we will explore various perspectives of benefit-risk within the lifecycle of product development. Presentations will touch on benefit-risk framework, incorporating benefit-risk into early clinical development, and incorporating patient preferences into benefit-risk assessment.
Speaker(s)
Regulatory Perspective/Framework
Hans-Georg Eichler, MD, MSC
Austrian Association of Social Security Bodies, Austria
Consulting Physician
Benefit-Risk: Quantitative/Qualitative Aspects
Lesley Wise, PHD, MSC
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Managing Director
Patient Perspective
Sally Okun, BSN, MHS, MBA, RN
Clinical Trials Transformation Initiative (CTTI), United States
Executive Director