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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">safetyrisk</journal-id><journal-title-group><journal-title xml:lang="ru">Безопасность и риск фармакотерапии</journal-title><trans-title-group xml:lang="en"><trans-title>Safety and Risk of Pharmacotherapy</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2312-7821</issn><issn pub-type="epub">2619-1164</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-34</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРЫ И ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS AND ORIGINAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>Система управления рисками - важная часть правил надлежащей практики фармаконадзора (GVP)</article-title><trans-title-group xml:lang="en"><trans-title>The risk management system as the important part of good pharmacovigilance practices (GVP)</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Казаков</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kazakov</surname><given-names>A. S.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Затолочина</surname><given-names>К. Э.</given-names></name><name name-style="western" xml:lang="en"><surname>Zatolochina</surname><given-names>K. E.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Романов</surname><given-names>Б. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Romanov</surname><given-names>B. K.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Букатина</surname><given-names>Т. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Bukatina</surname><given-names>T. M.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Вельц</surname><given-names>Н. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Velts</surname><given-names>N. Yu.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Научный центр экспертизы средств медицинского применения<country>Россия</country></aff><aff xml:lang="en">Scientific Centre for Expert Evaluation of Medicinal Products<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>20</day><month>02</month><year>2018</year></pub-date><volume>0</volume><issue>1</issue><fpage>21</fpage><lpage>27</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Казаков А.С., Затолочина К.Э., Романов Б.К., Букатина Т.М., Вельц Н.Ю., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Казаков А.С., Затолочина К.Э., Романов Б.К., Букатина Т.М., Вельц Н.Ю.</copyright-holder><copyright-holder xml:lang="en">Kazakov A.S., Zatolochina K.E., Romanov B.K., Bukatina T.M., Velts N.Y.</copyright-holder><license license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.risksafety.ru/jour/article/view/34">https://www.risksafety.ru/jour/article/view/34</self-uri><abstract><p>Система управления рисками включает в себя процесс определения вероятности наступления нежелательного эффекта фармакотерапии, выявление степени и величины риска, анализ и выбор стратегии управления риском, выбор необходимых для данной стратегии приемов управления риском и способов его снижения. Таким образом, система управления рисками является одним из современных и эффективных инструментов фармаконадзора, направленных на повышение эффективности и безопасности фармакотерапии.</p></abstract><trans-abstract xml:lang="en"><p>The risk management system includes the process of determining the probability of occurrence of undesirable effects of pharmacotherapy, identifying the extent and magnitude of the risk analysis and the choice of risk management strategy, the selection of necessary for this risk management techniques and strategies of ways to reduce it. Thus, the risk management system is a modern and efficient pharmacovigilance tools aimed to improve the effectiveness and safety of pharmacotherapy.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>система управления риском</kwd><kwd>нежелательная реакция</kwd><kwd>план управления рисками</kwd><kwd>фармаконадзор</kwd><kwd>risk management</kwd><kwd>adverse reaction</kwd><kwd>risk management plan</kwd><kwd>pharmacovigilance</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Guideline on good pharmacovigilance practices (GVP) - Module V (Rev 1) EMA/838713/2014[сайт]. URL: http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2012/06/WC500129134. pdf.</mixed-citation><mixed-citation xml:lang="en">Guideline on good pharmacovigilance practices (GVP) — Module V (Rev 1)  EMA/838713/2014 [Electronic resource]. 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Available at juristic  database «Consultant Plus» (cited 17.12.2015).</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
