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Documents
- Rommelag - PATH - Gates Foundation Grant BFS Final Report (PDF - 4 Mb)
- EU GMP guide Chap 8: Complaints, Quality Defects and Product Recalls (PDF - 265.7 kb)
- BFS Vaccine Technology - lowering aseptic risk (presentation slides) (PDF - 2.8 Mb)
- 2019 Rommelag Blow-Fill-Seal Technology _Engineering_FB (PDF - 631.3 kb)
- Rommelag CMO (PDF - 597.5 kb)
- 2019 Rommelag Vaccine Packaging CPAD ApiJect (PDF - 4.3 Mb)
- Acronyms and abbreviations (PDF - 53.6 kb)
- DCVMN Audit and Inspection (presentation slides) (PDF - 429.5 kb)
- DCVMN PSUR - PBRER (presentation slides) (PDF - 542.6 kb)
- DCVMN PV SP (presentation slides) (PDF - 1.5 Mb)
- Risk Management: An Industry Perspective (presentation slides) (PDF - 1.2 Mb)
- Signal Detection and Management (presentation slides) (PDF - 445.7 kb)
- EMA GPV Module XV Safety Communication (PDF - 180.7 kb)
- EMA GVP Module III Inspections (PDF - 183.6 kb)
- EMA GVP Module II PV System Master File PSMF (PDF - 323.1 kb)
- EMA GVP Module IV PV Audits (PDF - 146.5 kb)
- EMA GVP Module IX Signal Management (PDF - 275.4 kb)
- EMA GVP Module IX Signal Management Methodologies (PDF - 126 kb)
- EMA GVP Module I PV Quality Management Systems (PDF - 204.7 kb)
- EMA GVP Module VII PSUR (PDF - 1.4 Mb)
- EMA GVP Module VII PSUR Explanatory Notes (PDF - 219.1 kb)
- EMA GVP Module V Risk Management Systems (PDF - 496.8 kb)
- EMA GVP Module XVI Risk Minimisation Measures (PDF - 351.4 kb)
- EMA GVP Module XVI Risk Minimisation Measures Educational Material (PDF - 73.9 kb)
- EMA GVP PI Vaccine Pharmacovigilance (PDF - 427.7 kb)
- EMA Template RMP (PDF - 486.3 kb)
- WHO guide Good Storage Practices (PDF - 128.9 kb)
- ICH E17EWG_Step4_Multi-Regional Clinical Trials (PDF - 707.2 kb)
- ICH E19EWG_Step2_Optimisation Data Safety Collection (PDF - 121.9 kb)
- ICH E2A_Clinical Safety Data Definitions Standards (PDF - 125.4 kb)
- ICH E2C_R2_PBRER - PSUR (PDF - 715.5 kb)
- ICH E2D_Guideline (PDF - 161.8 kb)
- ICH E2E_Pharmacovigilance Planning (PDF - 180.4 kb)
- ICH E2F_DSUR (PDF - 258.9 kb)
- ICH E2F DSUR - EMA (PDF - 344.8 kb)
- ICH_E2F_step_4_October_2010 (PDF - 145.6 kb)
- ICH E3_Clinical Studies Report (PDF - 336.4 kb)
- Speakers’ book Sao Paulo (PDF - 221.3 kb)
- WHO-UMC system for standardised case causality assessment (PDF - 148.8 kb)
- Sao Paulo Workshop Agenda (PDF - 451.4 kb)
