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Presentation of Dr. Ute Roskoft
Documents
- Evaluation of Two Serological Methods for Potency Testing of Whole Cell Pertussis Vaccines (PDF - 3.1 Mb)
- Collaborative study on saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations (PDF - 2.2 Mb)
- A. Visala - CDSCO (presentation slides) (PDF - 1.6 Mb)
- C.v. Hunolstein - ISS (presentation slides) (PDF - 3.8 Mb)
- C. Rajanathan - Zydus Cadila (presentation slides) (PDF - 2.3 Mb)
- The consistency approach for quality control of vaccines - A strategy to improve quality control and implement 3Rs (PDF - 134.1 kb)
- D. Saha - USP (presentation slides) (PDF - 1 Mb)
- D. Wilkinson - NIBSC_Validation (presentation slides) (PDF - 2.2 Mb)
- D. Wilkinson - NIBSC_Rabies (presentation slides) (PDF - 728.9 kb)
- D. Wilkinson - NIBSC_Validation Plan Template (PDF - 178.9 kb)
- D. Wilkinson - NIBSC_Validation Report Template (PDF - 169.6 kb)
- S. Pagliusi - DCVMN Report (presentation slides) (PDF - 3 Mb)
- Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry - Draft Guidance - US FDA (PDF - 165 kb)
- Comparability Protocols for Human Drugs and Biologics: CMC Information - Draft Guidance - US FDA (PDF - 200.3 kb)
- Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization - Guidance for Industry - US FDA (PDF - 71.2 kb)
- Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry - US FDA (PDF - 133.8 kb)
- Quality Considerations for Continuous Manufacturing - Draft Guidance - US FDA (PDF - 197.3 kb)
- G. Singh - Bharat Biotech (presentation slides) (PDF - 669.2 kb)
- EMA Guidance for inividual laboratories for transfer of QC methods validated in collaborative trials with a view to implementing 3Rs (PDF - 129.9 kb)
- Workshop Agenda (PDF - 463.8 kb)
- N. Dellepiane - for DCVMN (presentation slides) (PDF - 218.8 kb)
- Network of Official Medicines Control Laboratories – Africa (NOMCoL Africa) Background Document (PDF - 208.5 kb)
- P. Peng - Tofflon (presentation slides) (PDF - 2.2 Mb)
- Quality control of vaccines-A journey from classical approach to 3Rs (PDF - 756.5 kb)
- S. Goel - SII - D_and_T (presentation slides) (PDF - 2.2 Mb)
- S. Goel - SII - Pertussis (presentation slides) (PDF - 1.3 Mb)
- S. Goel - SII - Rabies (presentation slides) (PDF - 2 Mb)
- S. Simon - BioZeen (presentation slides) (PDF - 2.3 Mb)
- S. Singh - NIB (presentation slides) (PDF - 3.3 Mb)
- Development and validation of magnetic bead pentaplex immunoassay for simultaneous quantification of murine serum IgG antibodies to acellular pertussis, diphtheria and tetanus antigens used in combination vaccines (PDF - 1.2 Mb)
- Speakers Book (PDF - 327.1 kb)
- Three Rs Approaches in the Quality Control of Inactivated Rabies Vaccines (PDF - 439.2 kb)
- WHO Manual for Quality Control of Diphtheria, Tetanus and Pertussis Vaccines (PDF - 2.4 Mb)
