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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Detaylı Bibliyografya
Yayımlandı:Vaccine X
Asıl Yazarlar: Dellepiane, Nora, Pagliusi, Sonia, Akut, Prashant, Comellas, Sebastian, De Clercq, Norbert, Ghadge, Shubhangi, Gastineau, Thierry, McGoldrick, Mic, Nurnaeni, Ida, Scheppler, Lorenz
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: Elsevier 2020
Konular:
Regular paper
Online Erişim: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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