Results of a Sociological Survey on the Needs of Drug Safety Monitoring Specialists for Information on the Creation of the Pharmacovigilance System Master File by N. G. Goloenko, R. I. Yagudina, A. Yu. Kulikov, V. G. Serpik, M. V. Protsenko, D. G. Karapetyan

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Typical pharmacovigilance system master file (PSMF) by B. K. Romanov, R. N. Alyautdin, S. V. Glagolev, V. A. Polivanov

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Expert Evaluation of Pharmacovigilance System Documents Included in the Registration Dossier by I. I. Snegireva, E. O. Zhuravleva, N. Yu. Velts

Subjects: “…pharmacovigilance system master file…”
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Post-approval variations to dossiers for vaccines: analysis of regulatory and methodological approaches used in the Russian Federation and abroad by 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

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Submission of Documents on the Pharmacovigilance System as Part of the Registration Dossier within the Framework of the EAEU Procedures: Analysis of Requirements and Typical Errors by N. Yu. Velts, E. O. Zhuravleva, G. V. Kutekhova, N. V. Tereshkina

Subjects: “…pharmacovigilance system master file…”
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