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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...

詳細記述

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書誌詳細
主要な著者: 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
フォーマット: Artigo
言語:Russo
出版事項: OOO “Vashe Tsifrovoe Izdatelstvo” 2019-03-01
シリーズ:Ведомости Научного центра экспертизы средств медицинского применения
主題:
オンライン・アクセス:https://www.vedomostincesmp.ru/jour/article/view/171
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