stadmin April 25, 2025 No Comments

Role & Responsibilities of Local Safety Unit 23rd – 25th June 2025

This basic pharmacovigilance training session is recommended for active or emerging Local Contact Persons Responsible for Pharmacovigilance (LCPRP) and/or deputy. Training structure includes presentations of following theoretical concepts, interactive sessions and customised case studies. Pharmacovigilance in medicines life cycle Case Management Risk Management Plan (RMP) Safety compliance Key Performance Indicators (KPIs) Non-compliance Pharmacovigilance System Master […]

stadmin August 26, 2024 No Comments

GxP Computer System Validation relationship with Quality Management System – 7-10 October 2025

Course description: This training session is recommended for personnel with previous experience in Quality Management System in GxP areas. Training structure includes presentations of following theoretical concepts, interactive sessions and customised case studies. GxP system Regulatory Requirements GxP Impact V Model Phases. Deliverables Computerised System lifecycle Responsibles & Main Responsibilities in IT System validation Risk […]