Zobrazeno 1 - 2
of 2
pro vyhledávání: '"периодический отчет по безопасности лекарственного препарата"'
Autor:
Yu. V. Olefir, B. K. Romanov, R. N. Alyautdin, V. K. Lepakhin, A. E. Krasheninnikov, E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 6, Iss 4, Pp 150-154 (2018)
The risk-based approach to pharmacovigilance control implemented in Russia since January 1, 2018 increases the responsibility of manufacturers and developers of medicines. The purpose of the work is to assess the system of Express reporting and Perio
Externí odkaz:
https://doaj.org/article/09793cbbc3ac47d799c56bed324ed9dc
Publikováno v:
Безопасность и риск фармакотерапии, Vol 5, Iss 4, Pp 148-160 (2018)
The results of evaluating information in the Periodic safety update reports (PSUR) submitted by marketing-authorisation holder indicate a lack of understanding of regulatory requirements for the preparation of this document. As a result PSURs submitt
Externí odkaz:
https://doaj.org/article/c7d4a967f5294f75837b79fca447538a