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pro vyhledávání: '"Prashant Akut"'
Autor:
Nora Dellepiane, Sonia Pagliusi, Prashant Akut, Sebastian Comellas, Norbert De Clercq, Shubhangi Ghadge, Thierry Gastineau, Mic McGoldrick, Ida Nurnaeni, Lorenz Scheppler
Publikováno v:
Vaccine: X, Vol 6, Iss , Pp 100075- (2020)
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
Externí odkaz:
https://doaj.org/article/46b229cc8edd444ca6e8e075bdd48a84
Autor:
Thierry Gastineau, Norbert De Clercq, Mic McGoldrick, Shubhangi Ghadge, Ida Nurnaeni, Prashant Akut, Nora Dellepiane, Sonia Pagliusi, Lorenz Scheppler, Sebastian Comellas
Publikováno v:
Vaccine: X
Vaccine: X, Vol 6, Iss, Pp 100075-(2020)
Vaccine: X, Vol 6, Iss, Pp 100075-(2020)
Highlights • Assessment of regulations and guidelines from 33 countries reveals complexity. • Variability of regulatory guidance for review and approval of manufacturing changes. • Reliance on the regulatory approval in the country of origin of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ff642ac93099d2e327439bc69a9420ff
http://europepmc.org/articles/PMC7516132
http://europepmc.org/articles/PMC7516132