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...

Disgrifiad llawn

Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Cyhoeddwyd yn:Vaccine X
Prif Awduron: Dellepiane, Nora, Pagliusi, Sonia, Akut, Prashant, Comellas, Sebastian, De Clercq, Norbert, Ghadge, Shubhangi, Gastineau, Thierry, McGoldrick, Mic, Nurnaeni, Ida, Scheppler, Lorenz
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: Elsevier 2020
Pynciau:
Regular paper
Mynediad Ar-lein: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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