Back to Agenda
The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
Session Chair(s)
Mayur 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 : Recognize ICSR replication and duplication challenges to the ecosystem; Describe ways to 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.
Speaker(s)
Panelist
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER
Panelist
Andrew Bate, PHD, MA
GSK, United Kingdom
Vice President, Head of Safety Innovation and Analytics
Panelist
Phil Tregunno
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director - Patient Safety Monitoring
Have an account?