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;
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monitoring, analysis and evaluation of information on drug safety;
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monitoring of local literature and web-sites;
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PSUR submission to Regulatory Authorities;
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CIOMS provision to the Regulatory Authorities;
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tracking changes in the legislation and other necessary actions related to the pharmacovigilance procedures implementation.