Pharmaceutical Regulatory Affairs: Open Access

Gildeeva GN

Publications

• Review Article
  Pharmacovigilance in the Russian Federation: Construction, Development and Reforms of PV System
  Author(s): Gildeeva GN and Belostotsky AVGildeeva GN and Belostotsky AV
  
  The review outlines the current issues of Pharmacovigilance System in the Russian Federation, namely present state of regulatory aspects of PV system in Russia, regulatory requirements in Russia and in Eurasian Economic Union, review of the causes of under-reporting of ADRs. Specific focus has been made on topical issues such as a harmonization of the requirements to the Pharmacovigilance System, currently underway in Russia, the issue of Guidelines on Good Pharmacovigilance Practice (GVP) in the Eurasian Economic Union. These actions are aimed at improving and harmonizing the rules governing the main aspects of the Pharmacovigilance System in the Russian Federation. Also the review analys.. Read More»
  DOI: 10.4172/2167-7689.1000187

  Abstract PDF