PV003: SOP FOR SAFETY DATA EXCHANGE AGREEMENTS (SDEA) & PARTNER RESPONSIBILITIES
OBJECTIVE: To define the procedure for establishing, reviewing, approving, and maintaining Safety Data Exchange Agreements (SDEA) with all partners involved in safety-related activities. To ensure compliance with World Health Organization (WHO) and European Union Good Pharmacovigilance Practices (EU-GVP) requirements. To clearly define safety responsibilities between the company and external partners for the exchange, reporting, and […]
PV002: SOP FOR PHARMACOVIGILANCE MASTER FILE (PSMF) PREPARATION & MAINTENANCE
OBJECTIVE: To define the procedure for preparation, approval, maintenance, and control of the Pharmacovigilance Master File (PSMF) in accordance with World Health Organization (WHO) guidelines, European Union Good Pharmacovigilance Practices (EU-GVP) Module II, and applicable national PV regulations. SCOPE: This SOP applies to all activities related to creating, updating, managing, and maintaining the PSMF for […]
PV001: SOP FOR PHARMACOVIGILANCE (PV) SYSTEM MANAGEMENT & QPPV RESPONSIBILITIES
OBJECTIVE: To define the system for managing Pharmacovigilance (PV) activities and to describe the responsibilities of the Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with WHO, EU-GVP, and local regulatory requirements. SCOPE: This SOP applies to all PV activities in the organization, including safety data collection, evaluation, reporting, maintenance of PV system documents, and […]
PV001: SOP FOR PHARMACOVIGILANCE (PV) SYSTEM MANAGEMENT & QPPV RESPONSIBILITIES
OBJECTIVE: To define the system for managing Pharmacovigilance (PV) activities and to describe the responsibilities of the Qualified Person for Pharmacovigilance (QPPV) to ensure compliance with WHO, EU-GMP, and local regulatory requirements. SCOPE: This SOP applies to all PV activities in the organization, including safety data collection, evaluation, reporting, maintenance of PV system documents, and […]