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Risk Management: New Directions
Session Chair(s)
Carla Barrett, PHARMD
Vice President, Global Risk Management, Novavax, United States
This session will hear from experts involved in digital risk minimization programs. They will describe how, following a Pharmacovigilance Risk Assessment Committee (PRAC) assessment report, a pilot was initiated to assess the feasibility and operational impact of developing and implementing digital additional risk minimization measures. The session will describe how a digital approach can support tool currency, continuous availability, and educational effectiveness. It will also cover aspects of internal vision development, global and local cross-functional collaboration, tool design, regulatory authority interactions, and the critical importance of change management.
Learning Objective : Identify opportunities for developing digital risk-benefit communications; Describe the organizational aspects of developing digital strategies from the lessons of ongoing programs; Describe the key impacts on people, process and tech in the move to utilise digital approaches for REMS and risk minimization that could be applied to their own organizations.
Speaker(s)
Helen Edelberg, MD, MPH, FACP
Deputy Office Director for Safety, Office of New Drugs, FDA, United States
Organizing for Digital Risk Minimization
Mark Perrott, PHD
Managing Partner, Axian Consulting Ltd., United Kingdom
Preparing for Digital in Benefit-Risk Management: Get Ready for the Revolution
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