Results of a Sociological Survey on the Needs of Drug Safety Monitoring Specialists for Information on the Creation of the Pharmacovigilance System Master File

The Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union oblige developers and marketing authorisation holders to implement a pharmacovigilance system that has to be described in the pharmacovigilance system master file (PSMF). Analysis of public sources revealed lack of data desc...

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Principais autores:	N. G. Goloenko, R. I. Yagudina, A. Yu. Kulikov, V. G. Serpik, M. V. Protsenko, D. G. Karapetyan
Formato:	Artigo
Idioma:	Russo
Publicado em:	Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2020-06-01
coleção:	Безопасность и риск фармакотерапии
Assuntos:	master file pharmacovigilance system medicinal product risk management system pharmacovigilance quality system sources of safety data annexes to master file
Acesso em linha:	https://www.risksafety.ru/jour/article/view/176
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