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.
Pharmacovigilance represents scientific research and activities aimed at identifying, evaluating, understanding, and prevention of possible adverse effects of medicines.
According to Resolution № 503 of the Cabinet of Ministers of the Republic of Azerbaijan dated On December 25, 2019 since 1st July 2020 came into force “Regulations of the pharmacovigilance of medicinal products”
Pharmexpert 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:
· QualifiedPerson for Pharmacovigilance (QPPV)
· National Persons Responsible for Pharmacovigilance (NPRP) in Azerbaijan Republic (also known as local QPPVs or LCP Local Contact Persons)
· 24/7 availability for pharmacovigilance
· Development and implementation of safety measures
· Continuous monitoring of the safety of drugs on the market
· Communications with NCA
· Monitoring of local resources
· Communication with patients and other sources of information on adverse events
· Preparation of Pharmacovigilance System Master-File (PSMF)
· Preparation of periodic notifications on cases of adverse events and reactions
· Preparationof Periodic Safety Update Reports (PSUR) of medicines
· Supporting of Expertise process of PV System by NCA
· Development of Standard Operating Procedures (SOP) for pharmaceutical manufacturers, marketing authorisation holders, representatives of pharmaceutical companies
· Archiving of documentation
The cost of pharmacovigilance work depends on the scope of rendered services and is determined individually.