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

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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Bibliographic Details
Main Authors: N. G. Goloenko, R. I. Yagudina, A. Yu. Kulikov, V. G. Serpik, M. V. Protsenko, D. G. Karapetyan
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2020-06-01
Series:Безопасность и риск фармакотерапии
Subjects:
master file
pharmacovigilance system
medicinal product
risk management system
pharmacovigilance quality system
sources of safety data
annexes to master file
Online Access:https://www.risksafety.ru/jour/article/view/176
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