Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers

A comparison of the regulations and guidelines from 33 countries, across different regions, on the requirements and procedures for the management of chemical, manufacturing and control (CMC) changes for vaccines, also known as post- approval changes (PACs), reveals significant variability and lack o...

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Detalhes bibliográficos
Publicado no:Vaccine X
Main Authors: Dellepiane, Nora, Pagliusi, Sonia, Akut, Prashant, Comellas, Sebastian, De Clercq, Norbert, Ghadge, Shubhangi, Gastineau, Thierry, McGoldrick, Mic, Nurnaeni, Ida, Scheppler, Lorenz
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier 2020
Assuntos:
Regular paper
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7516132/
https://ncbi.nlm.nih.gov/pubmed/32995745
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.jvacx.2020.100075
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