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.
According to the law of the Republic of Azerbaijan 1150-VQD dated May 18, 2018, in the country was introduced pharmacovigilance in order to regulate the activities of identifying, assessing, and preventing other undesirable consequences of using drugs.
Pharmacovigilance represents scientific research and activities aimed at identifying, evaluating, understanding, and prevention of possible adverse effects of medicines.
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:
- Qualified Person for Pharmacovigilance (QPPV)
- National Persons Responsible for Pharmacovigilance (NPRP) in Azerbaijan Republic (also known as local QPPVs or Local Contact Persons)
- 24 hours availability for pharmacovigilance
- Development of standard operating procedures for pharmaceutical manufacturers, marketing authorisation holders,representatives of pharmaceutical companies
- Development and implementation of safety measures
- Development of documentation on pharmacovigilance
- Continuous monitoring of the safety of drugs on the market
- Communications with regulatory authorities
- Communication with patients and other sources of information on adverse events
- Monitoring and analysis of adverse events in clinical studies
- Preparation of periodic notifications on cases of adverse events and reactions
- Preparation of periodic safety update reports on of medicines
- Collaboration with the quality assurance departments
- Archiving of documentation
The cost of pharmacovigilance work depends on the scope of rendered services and is determined individually.