Pharmacovigilance is one of the priority directions of development of public health throughout the world. Effective organisation of activities to identify, assess, and prevent adverse effects of administration of medicinal products are extremely relevant for all members of the health system.
On October 10, 2018, Moscow hosted the first International Scientific and Practical Conference “Pharmacovigilance – Contemporary Challenges and Opportunities” organised by the Federal Service for Supervision of Healthcare together with the Association of International Pharmaceutical Manufacturers. The conference was attended by over 600 people, including representatives of the Ministry of Health of the Russian Federation, subordinate expert organisations, employees of centres for safety monitoring of medicinal products, leading medical universities, Pharmacovigilance experts, as well as international experts on Pharmacovigilance of the WHO Collaborating Centre for International Drug Monitoring, Council for International Organisations of Medical Sciences (CIOMS), Eurasian Economic Commission, regulatory authorities of Armenia, Belarus, Kazakhstan, International Society of Pharmacovigilance (ISOP).
The conference discussed global trends in organisation of the pharmacovigilance system, important aspects of the legislation on pharmacovigilance within the Eurasian Economic Community (EAEC), harmonisation of Good Pharmacovigilance Practices with international approaches and practices, modern approaches to risk management, principles of signal identification, selection of the strategy for effective evaluation of the benefits and risks of medicinal products, topical aspects of safety of biological products. Special attention at the conference was given to the practical aspects of using the international coding standard for safety information MedDRA, work with the EAEC unified information database on the identified adverse reactions (effects) of medicinal products, including reports of ineffective medicinal products.
The Republic of Belarus, as the party responsible for development of the legislation on pharmacovigilance in the territory of the EAEC, presented the report on conceptual changes in the requirements of the legislation on pharmacovigilance, planned changes to the Rules of Good Pharmacovigilance Practices of the EAEC member states, as well as inspection procedures.
Participation in the conference allowed obtaining information on the advanced experience and best international practices in the field of safety monitoring of medicinal products, considering issues related to further development of the effective pharmacovigilance system in the EAEC member states. We hope that further joint efforts of all stakeholders will facilitate creation of an effective system to ensure patient safety and to reduce adverse effects of pharmacotherapy.