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Mandarin Oriental Washington D.C.

Jan 23, 2017 7:30 AM - Jan 25, 2017 3:15 PM

1330 Maryland Avenue, SW, Washington, DC 20024

Pharmacovigilance and Risk Management Strategies Conference

Session 8: Advances in Benefit-Risk

Session Chair(s)

Elizabeth E. Garrard, PharmD

Elizabeth E. Garrard, PharmD

Executive Vice President, Global Safety Operations

Clinipace Worldwide, United States

Benefit risk evaluation is key to decision-making for most stakeholders involved with innovative medicines. Whereas regulators evaluate it at a population based level, healthcare professionals and patients need to understand how it affects them at the individual level: “Is drug A the right treatment for me/my patient?” This session will explore different measures for looking at benefit risk and new ways in which the data can be visualized to facilitate decision making. A system which helps integrate evidence across different data sources for signal analysis will be demonstrated.

Speaker(s)

Tarek  Hammad, MD, PhD, MS, MSc, FISPE

Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement

Tarek Hammad, MD, PhD, MS, MSc, FISPE

Takeda, United States

Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera

Lesley  Wise, PhD, MSc

Presenting and Communicating Benefits and Risks for Medical Decision-Making: Innovative Visualization Methods

Lesley Wise, PhD, MSc

Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom

Managing Director

Mick  Foy

Integrating Evidence Across Multiple Data Sources for Signal Analysis: A Demonstration

Mick Foy

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Director of Delivery

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