SOP for Pharmacovigilance System Maintenance Guidelines for Pharmacovigilance System Maintenance 1) Purpose The purpose of this SOP is to outline procedures for the ongoing maintenance and support of pharmacovigilance systems…
SOP for Pharmacovigilance System Validation Guidelines for Pharmacovigilance System Validation 1) Purpose The purpose of this SOP is to establish procedures for validating pharmacovigilance systems to ensure compliance with regulatory…
SOP for Pharmacovigilance Safety Database Upgrades Guidelines for Pharmacovigilance Safety Database Upgrades 1) Purpose The purpose of this SOP is to define procedures for planning, executing, and validating upgrades to…
SOP for Pharmacovigilance Safety Database Lock Procedures Guidelines for Pharmacovigilance Safety Database Lock Procedures 1) Purpose The purpose of this SOP is to establish procedures for locking the pharmacovigilance safety…
SOP for Pharmacovigilance Aggregate Report Distribution Guidelines for Pharmacovigilance Aggregate Report Distribution 1) Purpose The purpose of this SOP is to define procedures for the distribution of pharmacovigilance aggregate reports…
SOP for Pharmacovigilance Expedited Reporting Criteria Guidelines for Pharmacovigilance Expedited Reporting Criteria 1) Purpose The purpose of this SOP is to establish criteria and procedures for identifying and reporting expedited…
SOP for Pharmacovigilance Causality Assessment Guidelines for Pharmacovigilance Causality Assessment 1) Purpose The purpose of this SOP is to establish procedures for conducting causality assessment of adverse events reported in…
SOP for Pharmacovigilance Seriousness Assessment Guidelines for Pharmacovigilance Seriousness Assessment 1) Purpose The purpose of this SOP is to provide guidelines for assessing the seriousness of adverse events reported in…
SOP for Pharmacovigilance Data Analysis and Reporting Guidelines for Pharmacovigilance Data Analysis and Reporting 1) Purpose The purpose of this SOP is to establish procedures for conducting pharmacovigilance data analysis…
SOP for Pharmacovigilance Data Entry and Verification Guidelines for Pharmacovigilance Data Entry and Verification 1) Purpose The purpose of this SOP is to establish standardized procedures for accurate and timely…