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…
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…
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…
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…
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…
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…
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…
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…
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…
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…