Search results - 26 results
Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use
Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health ...
Report of WHO Drafting Group meeting to revise WHO Guidelines on procedures and data requirements for changes to approved vaccines
(2023) Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of ...
OCABR: Respiratory Syncytial Virus (rDNA) Vaccine
p.15 (2023) Accession Number: PA/PH/OMCL (23) 3 DEF Keywords: EDQM guideline OCABR RSV Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des ...
WHO Drafting Group meeting to revise WHO Guidelines on PAC- outcome of workshops
approved vaccines, WHO, Frankfurt, Germany (2023) Keywords: post-approval changes vaccines WHO Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité ...
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision
Regulatory Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of ...
Method transfer of the hexavalent vaccine Vaxelis: a bumpy road with a happy ending
Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood ...
The Role of EDQM and OMCLs
(2017) Keywords: Vaccine conformity Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en ...
Evaluation of quality and non-clinical data for licencing of vaccines
Greece (2017) Keywords: vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en ...
Appoaching EMA and National regulatory authorties: who, when and how.
Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health ...
Panel discussion on CMC for vaccines: "Responding in Time: Dealing with Predictable and Unpredictable"
Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Full text language: English Category: C31 FOS Classification: 3.03 Health ...