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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Detalles Bibliográficos
Autores principales: Dellepiane, Nora, Pagliusi, Sonia, Akut, Prashant, Comellas, Sebastian, De Clercq, Norbert, Ghadge, Shubhangi, Gastineau, Thierry, McGoldrick, Mic, Nurnaeni, Ida, Scheppler, Lorenz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Regular paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7516132/
https://www.ncbi.nlm.nih.gov/pubmed/32995745
http://dx.doi.org/10.1016/j.jvacx.2020.100075

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