SOP for Pharmacovigilance Compliance Reporting Guidelines for Pharmacovigilance Compliance Reporting 1) Purpose The purpose of this SOP is to establish procedures for reporting pharmacovigilance compliance activities to ensure adherence to…
SOP for Pharmacovigilance Inspection Management Guidelines for Pharmacovigilance Inspection Management 1) Purpose The purpose of this SOP is to outline procedures for managing pharmacovigilance inspections conducted by regulatory authorities to…
SOP for Pharmacovigilance Adjudication Committee Guidelines for Pharmacovigilance Adjudication Committee 1) Purpose The purpose of this SOP is to define the roles, responsibilities, and procedures for the Pharmacovigilance Adjudication Committee…
SOP for Pharmacovigilance Risk Management Committee (RMC) Guidelines for Pharmacovigilance Risk Management Committee (RMC) 1) Purpose The purpose of this SOP is to define the roles, responsibilities, and procedures for…
SOP for Pharmacovigilance Case Triage Guidelines for Pharmacovigilance Case Triage 1) Purpose The purpose of this SOP is to establish procedures for the initial assessment and classification of incoming adverse…
SOP for Pharmacovigilance Signal Detection Activities Guidelines for Pharmacovigilance Signal Detection Activities 1) Purpose The purpose of this SOP is to establish procedures for the proactive detection, assessment, and management…
SOP for Pharmacovigilance Aggregate Report Submission Guidelines for Pharmacovigilance Aggregate Report Submission 1) Purpose The purpose of this SOP is to outline procedures for the preparation, review, and submission of…
SOP for Pharmacovigilance Risk Communication Plan Guidelines for Pharmacovigilance Risk Communication Plan 1) Purpose The purpose of this SOP is to establish procedures for identifying, evaluating, and communicating risks associated…
SOP for Pharmacovigilance Post-Authorization Safety Studies (PASS) Guidelines for Pharmacovigilance Post-Authorization Safety Studies (PASS) 1) Purpose The purpose of this SOP is to establish procedures for the planning, conduct, and…
SOP for Pharmacovigilance Development Safety Update Reports (DSUR) Guidelines for Pharmacovigilance Development Safety Update Reports (DSUR) 1) Purpose The purpose of this SOP is to outline procedures for the preparation,…