Post-approval variations to dossiers for vaccines: analysis of regulatory and methodological approaches used in the Russian Federation and abroad

The management of post-approval changes to registration dossiers for medicinal products is one of the most important factors for ensuring sustainable quality, safety and efficacy of medicines. Competent authorities that use the module format of the registration dossier, i.e. the regulatory authoriti...

Full beskrivning

Sparad:
Bibliografiska uppgifter
Huvudupphovsmän: V. A. Shevtsov, Yu. V. Olefir, V. A. Merkulov, V. P. Bondarev, I. N. Indikova, E. E. Evreinova, A. V. Rukavishnikov, L. M. Khantimirova, D. V. Gorenkov
Materialtyp: Artigo
Språk:Russo
Publicerad: OOO “Vashe Tsifrovoe Izdatelstvo” 2019-03-01
Serie:Ведомости Научного центра экспертизы средств медицинского применения
Ämnen:
quality evaluation
quality standards
changes
variations
registration dossier
master-file
vaccine antigen
vaccine
Länkar:https://www.vedomostincesmp.ru/jour/article/view/171
Taggar: Lägg till en tagg
Inga taggar, Lägg till första taggen!

Liknande verk