Annals of the Russian academy of medical sciencesAnnals of the Russian academy of medical sciencesВестник Российской академии медицинских наук0869-60472414-3545"Paediatrician" Publishers LLC23510.15690/vramn.v67i12.480PHARMACEUTICALS: CURRENT ISSUESАКТУАЛЬНЫЕ ВОПРОСЫ ФАРМАЦЕВТИКИREGULATORY SCIENCE: MODERN TRENDS IN SCIENCE AND EDUCATION FOR PHARMACEUTICAL PRODUCTSРЕГУЛЯТОРНАЯ НАУКА: СОВРЕМЕННЫЕ ТЕНДЕНЦИИ В НАУКЕ И ОБРАЗОВАНИИ В ОБЛАСТИ ЛЕКАРСТВЕННЫХ СРЕДСТВBeregovykhV. V.БереговыхВ. В.
Russian Federation

PhD, Corresponding Member of Russian Academy of Medical Sciences, Head of a Chair of Industrial Pharmacy, State Budget Educational Institution of Higher Professional Education First Moscow State Medical University named after I.M. Sechenov, Ministry of Health, Russian Academy of Medical Sciences Address: 119991, Moscow, Trubetskaya str. 8, bldg. 2; Tel.: (495) 698-52-59

osipova-mma@bk.ruPyatigorskayaN. V.ПятигорскаяН. В.
Russian Federation

PhD, Professor, Chair of Industrial Pharmacy, State Budget Educational Institution of Higher Professional Education First Moscow State Medical University named after I.M. Sechenov, Ministry of Health, Russian Academy of Medical Sciences Address: 119991, Moscow, Trubetskaya str. 8, bldg. 2

osipova-mma@bk.ruAladyshevaZh. I.АладышеваЖ. И.
Russian Federation

Candidate of Medical Sciences, Associate Professor, Chair of Industrial Pharmacy, State Budget Educational Institution of Higher Professional Education First Moscow State Medical University named after I.M. Sechenov, Ministry of Health, Russian Academy of Medical Sciences Address: 119991, Moscow, Trubetskaya str. 8, bldg. 2

osipova-mma@bk.ruThe First Moscow State Medical University named after I.M. Sechenov, Russian FederationПервый Московский государственный медицинский университет им. И.М. Сеченова, Российская Федерация101220126712Вестник Российской академии медицинских наук414607082015Copyright ©; 2012, "Paediatrician" Publishers LLCCopyright ©; 2012, Издательство "Педиатръ"2012"Paediatrician" Publishers LLCИздательство "Педиатръ"https://vestnikramn.spr-journal.ru/jour/about/submissionshttps://vestnikramn.spr-journal.ru/jour/article/view/235

This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term — «regulatory science» which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

В статье рассмотрены современные тенденции в развитии новых инструментов, стандартов и подходов к оценке безопасности, эффективности, качества и действия лекарственных средств в США и странах Европейского союза, объединяемые в настоящее время новым для Российской Федерации термином «регуляторная наука». Приведен обзор современных зарубежных образовательных программ, разработанных университетами США и стран Европейского союза за последние 3 года с целью подготовки кадров, требуемых для применения научного подхода при регулировании лекарственных средств. Представлены основные механизмы финансирования исследований в области регуляторной науки, используемые в США. В Российской Федерации пока такое направление науки и соответствующие исследования не проводятся, хотя потребность в них достаточно высока, так же как и необходимость в создании системы подготовки и повышения квалификации специалистов по регулированию лекарственных средств.

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