Pharmacovigilance support

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Pharmacovigilance support

Pharmacovigilance-related services for  the MAH and pharmaceutical plants:

 

  • collection, processing and reporting of information on drugs use-related  adverse events (ICSR);
  • monitoring of side effects of drugs;
  • monitoring, analysis and evaluation of information on drug safety;
  • monitoring of local literature and web-sites;
  • PSUR submission to Regulatory Authorities;
  • CIOMS provision to the Regulatory Authorities;
  • tracking changes in the legislation and other necessary actions related to the pharmacovigilance procedures implementation.

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