REGULATORY SCIENCE: MODERN TRENDS IN SCIENCE AND EDUCATION FOR PHARMACEUTICAL PRODUCTS

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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).

 

About the authors

V. V. Beregovykh

The First Moscow State Medical University named after I.M. Sechenov, Russian Federation

Author for correspondence.
Email: osipova-mma@bk.ru
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 Россия

N. V. Pyatigorskaya

The First Moscow State Medical University named after I.M. Sechenov, Russian Federation

Email: osipova-mma@bk.ru
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 Россия

Zh. I. Aladysheva

The First Moscow State Medical University named after I.M. Sechenov, Russian Federation

Email: osipova-mma@bk.ru
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 Россия

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