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The process of forwarding adverse event reports to partners, licensees, or other stakeholders as required by contractual agreements.
When the license holder receives an adverse event, they forward it to their licensing partner within the timeframe specified in their SDEA (typically 24-48 hours for serious cases).
Safety Data Exchange Agreements
Not tracking downstream distribution or missing partner-specific formatting requirements.
How do you manage downstream reporting to partners? Show me your tracking and reconciliation process.