Chemistry Manufacturing and Controls Fostering Implementation of Vaccine Release Test Methods Aimed at Reducing Animal Use (Hyderabad, India)

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Documents

Analytical Procedures and Methods Validation for Drugs and Biologics – Guidance for Industry – US FDA

Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry – Draft Guidance – US FDA

Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization – Guidance for Industry – US FDA

Comparability Protocols for Human Drugs and Biologics: CMC Information – Draft Guidance – US FDA

Quality Considerations for Continuous Manufacturing – Draft Guidance – US FDA

EMA Guidance for inividual laboratories for transfer of QC methods validated in collaborative trials with a view to implementing 3Rs

Evaluation of Two Serological Methods for Potency Testing of Whole Cell Pertussis Vaccines

Collaborative study on saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations

The consistency approach for quality control of vaccines – A strategy to improve quality control and implement 3Rs

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

Quality control of vaccines-A journey from classical approach to 3Rs

Speakers Book

WHO Manual for Quality Control of Diphtheria, Tetanus and Pertussis Vaccines

Three Rs Approaches in the Quality Control of Inactivated Rabies Vaccines

Network of Official Medicines Control Laboratories – Africa (NOMCoL Africa) Background Document

Workshop Agenda

N. Dellepiane – for DCVMN (presentation slides)

G. Singh – Bharat Biotech (presentation slides)

S. Goel – SII – Pertussis (presentation slides)

S. Singh – NIB (presentation slides)

D. Saha – USP (presentation slides)

S. Goel – SII – D_and_T (presentation slides)

C. Rajanathan – Zydus Cadila (presentation slides)

ute_rosskopf.mp4

S. Pagliusi – DCVMN Report (presentation slides)

D. Wilkinson – NIBSC_Validation (presentation slides)

D. Wilkinson – NIBSC_Validation Plan Template

D. Wilkinson – NIBSC_Validation Report Template

S. Simon – BioZeen (presentation slides)

A. Visala – CDSCO (presentation slides)

C.v. Hunolstein – ISS (presentation slides)

S. Goel – SII – Rabies (presentation slides)

P. Peng – Tofflon (presentation slides)

D. Wilkinson – NIBSC_Rabies (presentation slides)

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