Support with routine pharmacovigilance activities 24/7

PhV system is a system organized by the market authorization holders of medicinal products and authorized bodies to implement relevant PhV tasks and responsibilities, including:

  • Monitoring drug safety
  • Identifying  changes in  risk/benefit ratio of a drug
  • Implementing steps to ensure drug safety

PhV process is aimed at:

  • Preventing adverse effects/adverse reactions in humans that occurred after the use of registered medicinal product
  • Ensuring drug safety and effectiveness of medicinal products
Aleksandr Ivanov

Aleksandr Ivanov

Head of Strategic Consulting Department

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We deliver PhV-related services, including:

1. Assigning and monitoring interactions of QPPV.

2. Examining local legislation on taxation (including the requirements of the HQs /central office), and verify compliance with the requirements of the current Russian Federation and EAEU laws;

3. Putting together and updating PSMF;

4. Monitoring compliance with the updated requirements of the current legislation

5. Creating and updating SOPs;

6. Mapping, drug information collection;

7. Identifying potential sources of drug safety information;

  • Physician, pharmacist, patient,  manufacturer and/or MA holder, regulatory authorities;

8. Developing a drug safety reporting form;

9. The minimum amount of information to identify the case, location - corporate website, server;

10. Selecting the site where the information /employee in charge of information processing will be forwarded

11. Identifying appropriate ways for obtaining information

  • phone/fax, e-mail, Internet

12. Monitoring literature, official websites in the territories under monitoring

  • by INN and trade name, at least once a week

13. Arranging processing, analysis and coding of drug safety information

14. Arranging AEdatabase maintenance;

15. Forwarding safety-related messages to HQs, central office;

16. Determining procedure for developing PSUR and DSUR  to be forwarded to the authorized agency;

17. Arranging employee training

18. Developing the risk management systems;

19. Monitoring KPIs for assessing PhV effectiveness;

20. Storage of PhV documentation in line with the local requirements

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