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...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Argitaratua izan da:Vaccine X
Egile Nagusiak: Dellepiane, Nora, Pagliusi, Sonia, Akut, Prashant, Comellas, Sebastian, De Clercq, Norbert, Ghadge, Shubhangi, Gastineau, Thierry, McGoldrick, Mic, Nurnaeni, Ida, Scheppler, Lorenz
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: Elsevier 2020
Gaiak:
Regular paper
Sarrera elektronikoa: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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