Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

In Azerbaijan Republic drug safety regulates by Resolutions № 503 “Regulations of the pharmacovigilance of medicinal products” of the Cabinet of Ministers of the Republic of Azerbaijan dated On December 25, 2019 and №39 “Instructions on Good Pharmacovigilance Practices” of the Board of the Ministry of Health of the Republic of Azerbaijan dated On August 25, 2020.

PHARMEXPERT CRO company provides full range of services in the field of pharmacovigilance from preparation of a single notification to full support in the field of PV, which includes:

  • Set up and implementation of Pharmacovigilance System
  • Development and maintenance of Pharmacovigilance System Master File (PSMF)
  • 24/7 availability as of Qualified Person for Pharmacovigilance (QPPV) and Local contact person for Pharmacovigilance (Local QPPV)
  • International and Local Literature Review
  • Regulatory Intelligence Services
  • Authority Website Monitoring
  • Product Complaints Management & Reporting
  • Adverse Events Case Processing & Reporting
  • Signal detection and Management
  • Aggregate reports (PSUR/ PBRER/ PADERs)
  • Preparation/maintenance of Risk Management System (RMS), Risk Management Plan (RMP) and Risk Minimisation Activities
  • Direct Healthcare Professional Communication (DHPC) management
  • Safety Data Exchange Agreements (SDEA) preparation and maintenance
  • Training
  • Supporting of Expertise process of PV System by NCA
  • Audit and inspection readiness

Normative references

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