SOPs for Pharmacovigilance

The purpose of this SOP is to establish procedures for reporting pharmacovigilance compliance activities to ensure adherence to regulatory requirements and internal policies.
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The purpose of this SOP is to outline procedures for managing pharmacovigilance inspections conducted by regulatory authorities to ensure compliance with applicable regulations and guidelines.
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The purpose of this SOP is to define the roles, responsibilities, and procedures for the Pharmacovigilance Adjudication Committee in assessing and adjudicating individual case safety reports (ICSRs) in pharmacovigilance.
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The purpose of this SOP is to define the roles, responsibilities, and procedures for the Pharmacovigilance Risk Management Committee (RMC) in evaluating and managing risks associated with medicinal products.
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The purpose of this SOP is to establish procedures for the initial assessment and classification of incoming adverse event reports in pharmacovigilance.
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The purpose of this SOP is to establish procedures for the proactive detection, assessment, and management of signals related to adverse events or potential risks associated with medicinal products.
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The purpose of this SOP is to outline procedures for the preparation, review, and submission of pharmacovigilance aggregate reports to regulatory authorities.
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The purpose of this SOP is to establish procedures for identifying, evaluating, and communicating risks associated with medicinal products in pharmacovigilance.
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The purpose of this SOP is to establish procedures for the planning, conduct, and reporting of Post-Authorization Safety Studies (PASS) in pharmacovigilance.
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The purpose of this SOP is to outline procedures for the preparation, review, and submission of Development Safety Update Reports (DSURs) in pharmacovigilance.
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