SOP for Pharmacovigilance Medical Assessment Guidelines for Pharmacovigilance Medical Assessment 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting medical assessment of adverse events and other safety data in pharmacovigilance. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the medical assessment process, including medical assessors, safety physicians,…

SOP for Pharmacovigilance Medical Review Guidelines for Pharmacovigilance Medical Review 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting medical review of adverse event reports and other safety data in pharmacovigilance. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the medical review process, including medical reviewers, safety…

SOP for Pharmacovigilance Safety Review Committee (SRC) Guidelines for the Pharmacovigilance Safety Review Committee 1) Purpose 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. 2) Scope This SOP applies to all members of the Safety…

SOP for Pharmacovigilance Signal Evaluation Guidelines for Conducting Pharmacovigilance Signal Evaluation 1) Purpose 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. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the signal evaluation process,…

SOP for Pharmacovigilance Literature Review Guidelines for Conducting Pharmacovigilance Literature Review 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting literature reviews to identify and evaluate safety information on medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the literature review process, including safety specialists, medical…

SOP for Pharmacovigilance Literature Screening Guidelines for Conducting Pharmacovigilance Literature Screening 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting literature screening to identify relevant safety information on medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the literature screening process, including safety specialists, medical writers,…

SOP for Pharmacovigilance Benefit-Risk Assessment Guidelines for Conducting Pharmacovigilance Benefit-Risk Assessment 1) Purpose The purpose of this SOP is to establish standardized procedures for conducting benefit-risk assessments to evaluate the safety and efficacy of medicinal products. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the benefit-risk assessment process, including safety specialists, data…

SOP for Pharmacovigilance Risk Minimization Measures Guidelines for Implementing Pharmacovigilance Risk Minimization Measures 1) Purpose 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. 2) Scope This SOP applies to all pharmacovigilance personnel involved in…

SOP for Pharmacovigilance Line Listing Generation Guidelines for Generating Pharmacovigilance Line Listings 1) Purpose 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. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the creation and review of…

SOP for Pharmacovigilance Aggregate Analysis Guidelines for Conducting Pharmacovigilance Aggregate Analysis 1) Purpose 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. 2) Scope This SOP applies to all pharmacovigilance personnel involved in the analysis of aggregate safety data,…