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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">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</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">vedomostiregmed-120</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>ОБЗОРНЫЕ И ПРОБЛЕМНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>GENERAL AND TOPICAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>Применение методов Agile и Scrum при разработке программного обеспечения для автоматизации экспертизы лекарственных средств</article-title><trans-title-group xml:lang="en"><trans-title>Application of Agile and Scrum methods in software development for automation of medicinal products evaluation</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>Кошечкин</surname><given-names>К. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Koshechkin</surname><given-names>K. 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>Научный центр экспертизы средств медицинского применения</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2017</year></pub-date><pub-date pub-type="epub"><day>13</day><month>02</month><year>2018</year></pub-date><volume>7</volume><issue>1</issue><fpage>64</fpage><lpage>68</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Кошечкин К.А., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Кошечкин К.А.</copyright-holder><copyright-holder xml:lang="en">Koshechkin K.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.vedomostincesmp.ru/jour/article/view/120">https://www.vedomostincesmp.ru/jour/article/view/120</self-uri><abstract><p>Проведен анализ применения методов Agile и Scrum при разработке программного обеспечения для автоматизации экспертизы лекарственных средств. Обозначены основные роли участников и выполняемые ими действия. Описаны общие принципы ориентации на коммуникацию и контроль объема планируемых для реализации требований. Приведены числовые характеристики влияния методов Agile и Scrum на сокращение сроков разработки программного обеспечения. Показано, что внедрение данных методов позволяет управлять имеющимися ресурсами с целью эффективной реализации наиболее ценных возможностей информационных систем в кратчайшие сроки.</p></abstract><trans-abstract xml:lang="en"><p>Medicinal products evaluation is quite impossible without automation systems. In order to develop and update a large number of information systems, it is necessary either to have considerable resources, or to apply the methodology of adaptive management to projects development. The article analyzes application of Agile and Scrum methods in software development and outlines the key roles of the participants and the actions they perform. It also describes general principles of commitment to communication and control of the scope of proposed requirements. The article illustrates how these methods can reduce the time spent on software development and help manage available resources to harness information systems capacity.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>Agile</kwd><kwd>Scrum</kwd><kwd>CALS/PLM-технологии</kwd><kwd>жизненный цикл лекарственных средств</kwd><kwd>лабораторная информационная система</kwd><kwd>единое информационное пространство в сфере обращения лекарственных средств</kwd><kwd>информатизация здравоохранения</kwd><kwd>информатизация фармации</kwd><kwd>Agile</kwd><kwd>Scrum</kwd><kwd>CALS/PLM-technologies</kwd><kwd>medicines lifecycle</kwd><kwd>Laboratory Information Management System</kwd><kwd>framework of common information space in medicinal products lifecycle</kwd><kwd>health informatics</kwd><kwd>pharmacy informatics</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">Сазерленд Дж. Scrum. 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