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

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