Pharmacovigilance

Since 2016, ARS offers a full range of outsourcing services in the field of pre-registration and post-marketing pharmacovigilance (PVG) at the territory of the Eurasian Economic Union (EAEU), including:

 

  • Assignment of a Qualified person for pharmacovigilance (QPPV) at the EAEU territory including the 24/7 “hotline” availability;
  • Monitoring and assessment of adverse events at the clinical research stage;
  • Safety monitoring of marketed drugs;
  • Incorporation of a medicine into the ARS pharmacovigilance system Master File;
  • Literature screening to detect adverse events (AE);
  • Preparation of Periodic safety update reports (PSUR) and Development safety update reports (DSUR);
  • Preparation of Risk management plans (RMP) for registration dossiers;
  • Interaction with regulatory bodies and representatives of a Partner including reporting adverse events to the regulatory bodies and responding pharmacovigilance regulatory authorities’ requests.