Main functions:
evaluation of medicine safety documentation included in submissions for marketing authorisation, re-authorisation, and variations to marketing authorisation of medicinal products according to the Russian national or the Eurasian marketing authorisation procedures;
research on medicine safety;
education (holding seminars and symposia on pharmacotherapy safety) and training of pharmacovigilance specialists;
international cooperation in the area of medicine safety (interaction with foreign centres for adverse reaction monitoring, cooperation with the WHO, EAEU, etc.);
analysis of decisions on medicine side effects, made by foreign and international regulatory agencies;
monitoring of publications in Russian and foreign periodicals for updated information on pharmacotherapy safety;
briefing of healthcare and pharmacy professionals on relevant issues of medicine safety.
Main objectives:
evaluation of compliance of the pharmacovigilance system documentation and risk management plans included in submissions for marketing authorisation, re-authorisation, and variations to marketing authorisation of medicinal products (including immunobiological products) with the medicine safety requirements established in the Russian Federation and the Eurasian Economic Union;
analysis and integration of medicine safety information, including analysis of side effects, serious adverse reactions revealed in clinical trials and post-authorisation studies;
analysis and integration of data on side effects of immunobiological products, including post-vaccination reactions;
scientific research in accordance with the FSBI ‘SCEEMP’ Plan of Publicly-Funded R&D Projects, approved by the Ministry of Health of Russia;
interaction with the World Health Organisation and other foreign and international agencies on issues related to pharmacotherapy safety, development of serious adverse reactions, unexpected adverse reactions;
monitoring of publications in Russian and foreign periodicals, decisions by foreign and international regulatory agencies, activities of foreign centres for adverse reaction monitoring, and analysis of available information on medicines safety;
informing healthcare and pharmacy professionals about relevant issues of medicines safety through publications in the Safety and Risk of Pharmacotherapy journal;
assessment of draft standards of care in terms of medicine safety;
determination of classification criteria for medicines, as requested by the Ministry of Health of Russia;
holding seminars to train pharmaceutical industry professionals in medicine safety;
development of guidelines on pharmacotherapy safety.