May 27 - 30, 2019Sao Paulo,Brazil Download the agenda Documents Sao Paulo Workshop Agenda WHO guide Good Storage Practices EU GMP guide Chap 8: Complaints, Quality Defects and Product Recalls Speakers’ book Sao Paulo WHO-UMC system for standardised case causality assessment BFS Vaccine Technology – lowering aseptic risk (presentation slides) 2019 Rommelag Blow-Fill-Seal Technology _Engineering_FB Rommelag CMO 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 IV PV Audits 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 VII PSUR EMA GVP Module XVI Risk Minimisation Measures Educational Material EMA GVP Module XVI Risk Minimisation Measures EMA GVP PI Vaccine Pharmacovigilance EMA Template RMP ICH E2A_Clinical Safety Data Definitions Standards ICH E2C_R2_PBRER – PSUR ICH E2D_Guideline ICH E2E_Pharmacovigilance Planning ICH E2F DSUR – EMA ICH E2F_DSUR ICH E3_Clinical Studies Report ICH E17EWG_Step4_Multi-Regional Clinical Trials ICH E19EWG_Step2_Optimisation Data Safety Collection ICH_E2F_step_4_October_2010 Acronyms and abbreviations 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) PATH PV systems Master File PATH PV Quality systems WHO Vaccine safety basics Highlights PATH PV definitions
