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Integrated Life Cycle Approaches to Benefit -Risk Assessment, Communication, and Evaluation
Session Chair(s)
Simon Ingate, PhD, MBA
Engagement Manager
Axian Consulting Limited, United Kingdom
Effective benefit-risk (B-R) communication is important in ensuring that key stakeholders understand how to use medicines appropriately. It requires the creation of processes to deliver communications that are relevant to their audiences, robust dissemination mechanisms, and evaluations to show they promote behaviors optimizing B-R. This session will address these areas.
Learning Objective : Identify the importance of effective benefit-risk communication.
Speaker(s)
Digital Strategies for Communicating Benefit-Risk and Gathering Effectiveness and Other Data Used to Optimize the Benefit-Risk Ratio
Simon Ingate, PhD, MBA
Axian Consulting Limited, United Kingdom
Engagement Manager
Learnings from Implementing Risk Minimization Measure Effectiveness Evaluation PASS Studies
Helen Edelberg, MD, MPH, FACP
FDA, United States
Deputy Office Director for Safety, Office of New Drugs
Benefit-Risk Communication Strategies: The Patient as a Partner
Dinah Duarte, MSc
European Medicines Agency, Netherlands
Signal Management Lead
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