Documents
WHO guide Good Storage Practices
EU GMP guide Chap 8: Complaints, Quality Defects and Product Recalls
WHO-UMC system for standardised case causality assessment
BFS Vaccine Technology – lowering aseptic risk (presentation slides)
2019 Rommelag Blow-Fill-Seal Technology _Engineering_FB
2019 Rommelag Vaccine Packaging CPAD ApiJect
Rommelag – PATH – Gates Foundation Grant BFS Final Report
EMA GPV Module XV Safety Communication
EMA GVP Module I PV Quality Management Systems
EMA GVP Module II PV System Master File PSMF
EMA GVP Module III Inspections
EMA GVP Module IX Signal Management Methodologies
EMA GVP Module IX Signal Management
EMA GVP Module V Risk Management Systems
EMA GVP Module VII PSUR Explanatory Notes
EMA GVP Module XVI Risk Minimisation Measures Educational Material
EMA GVP Module XVI Risk Minimisation Measures
EMA GVP PI Vaccine Pharmacovigilance
ICH E2A_Clinical Safety Data Definitions Standards
ICH E2E_Pharmacovigilance Planning
ICH E3_Clinical Studies Report
ICH E17EWG_Step4_Multi-Regional Clinical Trials
ICH E19EWG_Step2_Optimisation Data Safety Collection
DCVMN Audit and Inspection (presentation slides)
DCVMN PSUR – PBRER (presentation slides)
DCVMN PV SP (presentation slides)
Risk Management: An Industry Perspective (presentation slides)
Signal Detection and Management (presentation slides)
WHO Vaccine safety basics Highlights
