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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">pharmjournal</journal-id><journal-title-group><journal-title xml:lang="ru">Разработка и регистрация лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Drug development &amp; registration</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2305-2066</issn><issn pub-type="epub">2658-5049</issn><publisher><publisher-name>LLC «CPHA»</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-98</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>ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>DRUG PRODUCTS EFFICACY AND SAFETY</subject></subj-group></article-categories><title-group><article-title>«МЕДИЦИНСКИЕ ПИСАТЕЛИ»: ВОЗРАСТАЮЩАЯ ПОТРЕБНОСТЬ ОТРАСЛИ</article-title><trans-title-group xml:lang="en"><trans-title>MEDICAL WRITERS: INCREASING NEED OF INDUSTRY</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>Кобякова</surname><given-names>О. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kobyakova</surname><given-names>O. 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>Куликов</surname><given-names>Е. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kulikov</surname><given-names>E. 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>Деев</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Deev</surname><given-names>I. A.</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>Дмитриев</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Dmitriev</surname><given-names>A. A.</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>Тюфилин</surname><given-names>Д. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Tyufilin</surname><given-names>D. 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>Пименов</surname><given-names>И. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Pimenov</surname><given-names>I. D.</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>Табакаев</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Tabakaev</surname><given-names>N. A.</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"><institution>ГБОУ ВПО «Сибирский государственный медицинский университет»</institution></aff><aff xml:lang="en"><institution>Siberian State Medical University</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>09</day><month>01</month><year>2019</year></pub-date><volume>0</volume><issue>2</issue><fpage>166</fpage><lpage>170</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Кобякова О.С., Куликов Е.С., Деев И.А., Дмитриев А.А., Тюфилин Д.С., Пименов И.Д., Табакаев Н.А., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Кобякова О.С., Куликов Е.С., Деев И.А., Дмитриев А.А., Тюфилин Д.С., Пименов И.Д., Табакаев Н.А.</copyright-holder><copyright-holder xml:lang="en">Kobyakova O.S., Kulikov E.S., Deev I.A., Dmitriev A.A., Tyufilin D.S., Pimenov I.D., Tabakaev N.A.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" 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.pharmjournal.ru/jour/article/view/98">https://www.pharmjournal.ru/jour/article/view/98</self-uri><abstract><p>В условиях возрастающей потребности отечественной фармацевтической и медицинской отрасли в качественной разработке и апробации новых лекарственных средств и изделий медицинского назначения подготовка специалистов в области комплексного проектирования клинических исследований и испытаний является крайне актуальной задачей. В этой связи в данном исследовании был проведен анализ трудовых функций таких специалистов при помощи анкетирования потенциальных работодателей. На основании полученных в ходе анализа данных сформирован перечень задач профессиональной деятельности и/или трудовых функций «медицинских писателей», соответствующий потребностями компаний-работодателей.</p></abstract><trans-abstract xml:lang="en"><p>Due to increasing needs in new domestic medical drugs and devices, it's becoming very topical to train complex design specialists of clinical trials and medical devices tests. Because of it in this research we surveyed main skills and required competence for such specialists by questioning potential companies-employers. All data we obtained allowed us to make a list of professional activity tasks and/or job functions for «medical writers» that correlates with the needs of companies-employers.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>проектирование клинических исследований</kwd><kwd>образовательная программа</kwd><kwd>клинические исследования</kwd></kwd-group><kwd-group xml:lang="en"><kwd>«medical writers»</kwd><kwd>clinical trials design</kwd><kwd>educating program</kwd><kwd>clinical trials</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">Федеральная целевая программа «Развитие фармацевтической и медицинской промышленности Российской Федерации на период до 2020 года и дальнейшую перспективу». 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