Open AccessREGULATORY SCIENCE: MODERN TRENDS IN SCIENCE AND EDUCATION FOR PHARMACEUTICAL PRODUCTS
Author(s) -
В. В. Береговых,
N.V. Pyatigorskaya,
Ж И Аладышева
Publication year - 2012
Publication title -
vestnik rossijskoj akademii medicinskih nauk
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.122
H-Index - 15
eISSN - 2414-3545
pISSN - 0869-6047
DOI - 10.15690/vramn.v67i12.480
Subject(s) - regulatory science , russian federation , curriculum , regulatory affairs , principal (computer security) , political science , engineering ethics , order (exchange) , workforce , quality (philosophy) , higher education , business , food and drug administration , public relations , public administration , medicine , engineering , computer science , risk analysis (engineering) , finance , economic policy , philosophy , pathology , epistemology , law , operating system
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).