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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)
Hans-Georg Eichler, MD, MSC
Consulting Physician, Austrian Association of Social Security Bodies, Austria
Regulatory Perspective/Framework
Lesley Wise, PHD, MSC
Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Benefit-Risk: Quantitative/Qualitative Aspects
Sally Okun, BSN, MHS, MBA, RN
Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Patient Perspective
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