Abstract
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).
Highlights
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»
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 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
Summary
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». Самое большое и авторитетное агентство мира по лекарственным средствам — Управление контроля качества продуктов и лекарственных средств США (Food and Drug Administration, FDA) — 24 февраля 2010 г. В программном документе Инициативы под названием «Стратегический план по развитию регуляторной науки в FDA (август 2011)» агентство привело определение термина «регуляторная наука», основные области применения Инициативы, условия и механизмы реализации. 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. Курсы образовательной программы магистра по регуляванное Агентство по защите окружающей среды США торной науке, предлагаемые Университетом Южной Калифорнии (EPA) было вынуждено принимать решения на основе
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