SOP for Pharmacovigilance Clinical Trials Safety Reporting Guidelines for Pharmacovigilance Clinical Trials Safety Reporting 1) Purpose The purpose of this SOP is to outline procedures for the monitoring, evaluation, and…
SOP for Pharmacovigilance Risk Management Activities Guidelines for Pharmacovigilance Risk Management Activities 1) Purpose The purpose of this SOP is to establish procedures for the identification, assessment, and management of…
SOP for Pharmacovigilance Safety Signal Investigation Guidelines for Pharmacovigilance Safety Signal Investigation 1) Purpose The purpose of this SOP is to outline procedures for the investigation and evaluation of safety…
SOP for Pharmacovigilance Medical Device Reporting Guidelines for Pharmacovigilance Medical Device Reporting 1) Purpose The purpose of this SOP is to establish procedures for reporting adverse events associated with medical…
SOP for Pharmacovigilance International Conference on Harmonization (ICH) Guidelines Compliance Guidelines for Pharmacovigilance ICH Guidelines Compliance 1) Purpose The purpose of this SOP is to ensure compliance with International Conference…
SOP for Pharmacovigilance Medical Dictionary for Regulatory Activities (MedDRA) Coding Guidelines for Pharmacovigilance MedDRA Coding 1) Purpose The purpose of this SOP is to establish standardized procedures for the coding…
SOP for Pharmacovigilance Database Query Management Guidelines for Pharmacovigilance Database Query Management 1) Purpose The purpose of this SOP is to establish procedures for managing queries in the pharmacovigilance database…
SOP for Pharmacovigilance Signal Evaluation and Prioritization Guidelines for Pharmacovigilance Signal Evaluation and Prioritization 1) Purpose The purpose of this SOP is to define procedures for the systematic evaluation, prioritization,…
SOP for Pharmacovigilance Aggregate Report Approval Guidelines for Pharmacovigilance Aggregate Report Approval 1) Purpose The purpose of this SOP is to establish procedures for the review, approval, and submission of…
SOP for Pharmacovigilance Case Narratives Review Guidelines for Pharmacovigilance Case Narratives Review 1) Purpose The purpose of this SOP is to define procedures for reviewing and assessing pharmacovigilance case narratives…