Pharmacovigilance of Medicinal Products
We handle interaction with regulatory authorities, ensure compliance with legislation, and officially represent the interests of the manufacturer
Pharmacovigilanc
— It is a set of activities aimed at identifying, analyzing, and preventing adverse reactions associated with the use of medicinal products.
What Does the Pharmacovigilance Service Include?
Weekly search of local literature (specialized newspapers, journals, websites) and screening of Ministry of Health websites.
Monthly or Quarterly Reports (as per client’s preference) on local literature searches and website monitoring.
Timely Response to Adverse Drug Reactions by notifying the manufacturer and the regulatory authority.
Handling CIOMs/MAH Reports – processing and analyzing data, preparing line listings, compiling monthly summary reports, and submitting them to the authorized regulatory authority.
Activities Related to PSUR Submission – including preparation of cover letters, translations, submission of the final PSUR to regulatory authorities, providing a PSUR submission schedule, and monitoring timeliness and status in accordance with local legislation.
Client Updates on New National Pharmacovigilance Laws and Regulations in the Republic of Kazakhstan.
Registration as Local QPPV and Coordination with the authorized government body and users, including 24/7 availability.
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