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Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward
Session Chair(s)
Andrew Bate, PhD, MA
Vice President, Head of Safety Innovation and Analytics
GlaxoSmithKline, United Kingdom
The current paradigm of repeated safety report transmission to multiple regulators results in greater noise, duplicative effort, more lag time, and diverted focus from protecting patients and building trust through a shared proactive safety science. Might international collaboration evolve in this era of real-world evidence to no longer require such continual circulation of the same adverse event reports? Might newer technologies be leveraged for a more effective modern system? What are the options and the issues that would need to be considered to realize this future state? A panel of regulators and international stakeholders will discuss the issues.
Learning Objective : Identify the issue and extent of international replication of safety reports; Discuss the possibility of leveraging modern processes or technical solutions (e.g., blockchain or decentralized networks) to enable more effective international collaboration; Determine how to move this agenda forward by focusing on patient safety in light of challenges and opportunities.
Speaker(s)
Paradigm Shift in Adverse Event Report Management and Sharing: Industry Update
Mayur A Patel, PharmD
AstraZeneca, United States
Vice President, Oncology Therapy Area, Global Patient Safety
Regulatory Perspective on AE Report Management and Sharing and Future Directions
Phil Tregunno
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director - Patient Safety Monitoring
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