Pharmacovigilance and Risk Management Strategies 2016

Discuss opportunities, challenges, and practical aspects of managing risk in the context of benefits, for medical product safety and pharmacovigilance.

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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