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Pharmacovigilance quality system 


  • Planning, ensuring, controlling and improving quality management of Pharmacovigilance System.

  • Organization and carrying out of internal audit (self-inspection) of Applicant’s Pharmacovigilance System.

  • Constant compliance monitoring of Pharmacovigilance System with requirements of current legislation.

  • Initial and periodic training of company’s staff on monitoring the safety and efficacy of medicinal products in accordance with regulatory requirements.

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