SOPs for Pharmacovigilance

The purpose of this SOP is to outline procedures for the ongoing maintenance and support of pharmacovigilance systems to ensure continuous functionality, data integrity, and compliance with regulatory requirements.
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The purpose of this SOP is to establish procedures for validating pharmacovigilance systems to ensure compliance with regulatory requirements and data integrity standards.
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The purpose of this SOP is to define procedures for planning, executing, and validating upgrades to the pharmacovigilance safety database to enhance functionality, performance, and compliance.
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The purpose of this SOP is to establish procedures for locking the pharmacovigilance safety database at predefined intervals to ensure data integrity and regulatory compliance.
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The purpose of this SOP is to define procedures for the distribution of pharmacovigilance aggregate reports to regulatory authorities, marketing authorization holders (MAHs), and other stakeholders in compliance with regulatory requirements.
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The purpose of this SOP is to establish criteria and procedures for identifying and reporting expedited safety reports of suspected serious adverse reactions (SUSARs) to regulatory authorities within defined timelines.
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The purpose of this SOP is to establish procedures for conducting causality assessment of adverse events reported in pharmacovigilance to determine the likelihood of a causal relationship between medicinal products and adverse events.
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The purpose of this SOP is to provide guidelines for assessing the seriousness of adverse events reported in pharmacovigilance to determine appropriate regulatory reporting and risk management actions.
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The purpose of this SOP is to establish procedures for conducting pharmacovigilance data analysis and preparing accurate and timely safety reports to regulatory authorities and stakeholders.
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The purpose of this SOP is to establish standardized procedures for accurate and timely data entry and verification in pharmacovigilance to ensure data quality and compliance with regulatory requirements.
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