SOP for Pharmacovigilance Medical Assessment
The purpose of this SOP is to establish standardized procedures for conducting medical assessment of adverse events and other safety data in pharmacovigilance.
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SOPs for Pharmacovigilance
SOP for Pharmacovigilance Medical Review
The purpose of this SOP is to establish standardized procedures for conducting medical review of adverse event reports and other safety data in pharmacovigilance.
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SOP for Pharmacovigilance Safety Review Committee (SRC)
The purpose of this SOP is to establish standardized procedures for the functioning of the Safety Review Committee (SRC) to ensure comprehensive evaluation and decision-making on safety-related issues.
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SOP for Pharmacovigilance Signal Evaluation
The purpose of this SOP is to establish standardized procedures for the evaluation of safety signals to determine their impact on the benefit-risk profile of medicinal products.
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SOP for Pharmacovigilance Literature Review
The purpose of this SOP is to establish standardized procedures for conducting literature reviews to identify and evaluate safety information on medicinal products.
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SOP for Pharmacovigilance Literature Screening
The purpose of this SOP is to establish standardized procedures for conducting literature screening to identify relevant safety information on medicinal products.
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SOP for Pharmacovigilance Benefit-Risk Assessment
The purpose of this SOP is to establish standardized procedures for conducting benefit-risk assessments to evaluate the safety and efficacy of medicinal products.
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SOP for Pharmacovigilance Risk Minimization Measures
The purpose of this SOP is to establish standardized procedures for the identification, implementation, and monitoring of risk minimization measures in pharmacovigilance to ensure the safety of medicinal products.
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SOP for Pharmacovigilance Line Listing Generation
The purpose of this SOP is to establish standardized procedures for generating line listings of adverse event (AE) data for regulatory reporting and internal analysis.
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SOP for Pharmacovigilance Aggregate Analysis
The purpose of this SOP is to establish standardized procedures for conducting aggregate analysis of safety data to identify trends, patterns, and potential safety signals.
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