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 regulatory requirements and internal policies. 2) Scope This SOP applies to the Pharmacovigilance (PV) department and personnel responsible for monitoring and reporting pharmacovigilance compliance metrics….

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 ensure compliance with applicable regulations and guidelines. 2) Scope This SOP applies to the Pharmacovigilance (PV) department and relevant stakeholders involved in preparing for and…

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 in assessing and adjudicating individual case safety reports (ICSRs) in pharmacovigilance. 2) Scope This SOP applies to members of the Pharmacovigilance Adjudication Committee within the…

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 the Pharmacovigilance Risk Management Committee (RMC) in evaluating and managing risks associated with medicinal products. 2) Scope This SOP applies to members of the Pharmacovigilance…

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 event reports in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for triaging adverse event reports within the organization. 3) Responsibilities The Pharmacovigilance…

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 of signals related to adverse events or potential risks associated with medicinal products. 2) Scope This SOP applies to pharmacovigilance personnel responsible for signal detection…

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 pharmacovigilance aggregate reports to regulatory authorities. 2) Scope This SOP applies to pharmacovigilance personnel responsible for compiling, verifying, and submitting aggregate reports within the organization….

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 with medicinal products in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for developing, implementing, and monitoring risk communication strategies within the organization….

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 reporting of Post-Authorization Safety Studies (PASS) in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for the design, execution, and oversight of PASS…

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, review, and submission of Development Safety Update Reports (DSURs) in pharmacovigilance. 2) Scope This SOP applies to pharmacovigilance personnel responsible for the preparation, review, and…