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

• Main Authors: N. G. Goloenko (Author), R. I. Yagudina (Author), A. Yu. Kulikov (Author), V. G. Serpik (Author), M. V. Protsenko (Author), D. G. Karapetyan (Author)
• Format: Book
• Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2020-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...