Pharmacovigilance

Since 2016 ARS has provided a full range of pharmacovigilance services in accordance with the requirements of GVP of the EEU:

  • Providing a 24/7 hotline
  • Pharmacovigilance trainings
  • Processing of ICSR at the territory of the Russian Federation (signal management, collection, validation, medical assessment, reporting)
  • Maintenance of a database of Individual Case Safety Report (ICSR)
  • Scientific and medical literature and other source screening to detect spontaneous safety reports
  • Submission of Periodic Safety Update Report (PSUR) to the Regulatory authorities
  • Monitoring the benefit-risk ratio
  • Developing of risk management plans

 

Our competitive advantages:

5+   years of experience in this field

40 +Periodic Safety Update Reports and Development Safety Update Reports