Adverse Event Intake and Reporting SOP
3 800 Skr
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Purpose:
Defines the process for intake, documentation, assessment, and reporting of adverse events to support pharmacovigilance activities and regulatory reporting obligations.
Regulatory Alignment:
Aligned with EU pharmacovigilance requirements (EU GVP) and relevant EU GMP expectations for quality system interfaces with safety reporting activities.
Included Files:
• SOP – Adverse Event Intake and Reporting
• Adverse event intake and documentation form
• Reporting timelines and responsibility overview
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical manufacturers, marketing authorisation holders, quality assurance teams, and pharmacovigilance personnel responsible for adverse event management and reporting.