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The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
Session Chair(s)
Mayur A Patel, PharmD
Vice President, Oncology Therapy Area, Global Patient Safety
AstraZeneca, United States
The pharmacovigilance (PV) ecosystem is fraught with noise, impeding a single source of truth for effective and timely safety surveillance of Individual Case Safety Reports (ICSRs). However, multi-stakeholder partnerships can synthesize diverse needs and requirements to pilot a modernized future state.
Learning Objective : Understand ICSR replication and duplication challenges to the ecosystem; Critically appraise a proposed concept for modernizing ICSR management to address challenges, enhance safety analysis, and facilitate a real-time learning healthcare system; Identify the stakeholder perspectives, modern methods and technologies, and change management needed to design and pilot a new ICSR paradigm.
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