{"id":13656,"date":"2025-12-30T16:25:00","date_gmt":"2025-12-30T13:25:00","guid":{"rendered":"https:\/\/sttd.com.ua\/?p=13656"},"modified":"2026-01-22T16:22:06","modified_gmt":"2026-01-22T13:22:06","slug":"proizvodstvo-issleduemyh-lekarstvennyh-sredstvimp-investigational-medicinal-products-ponyatiya-i-trebovaniya-na-osnove-sovremennyh-mezhdunarodnyh-rukovodstv","status":"publish","type":"post","link":"https:\/\/sttd.com.ua\/ru\/proizvodstvo-issleduemyh-lekarstvennyh-sredstvimp-investigational-medicinal-products-ponyatiya-i-trebovaniya-na-osnove-sovremennyh-mezhdunarodnyh-rukovodstv\/","title":{"rendered":"\u041f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u043e \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432(IMP \u2013 Investigational Medicinal Products) \u2013\u041f\u043e\u043d\u044f\u0442\u0438\u044f \u0438 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f \u043d\u0430 \u043e\u0441\u043d\u043e\u0432\u0435 \u0441\u043e\u0432\u0440\u0435\u043c\u0435\u043d\u043d\u044b\u0445 \u043c\u0435\u0436\u0434\u0443\u043d\u0430\u0440\u043e\u0434\u043d\u044b\u0445 \u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432"},"content":{"rendered":"\n<p><strong>\u0412\u0440\u0435\u043c\u044f \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u0438\u044f:<\/strong>&nbsp;10.00 \u2013 13.00 \u043f\u043e \u043a\u0438\u0435\u0432\u0441\u043a\u043e\u043c\u0443 \u0432\u0440\u0435\u043c\u0435\u043d\u0438<\/p>\n\n\n\n<p><strong>\u0410\u0432\u0442\u043e\u0440 \u0438 \u0432\u0435\u0434\u0443\u0449\u0438\u0439:<\/strong> <strong>\u041d\u0438\u043a\u0438\u0442\u044e\u043a \u0412\u0430\u043b\u0435\u0440\u0438\u0439 \u0413\u0440\u0438\u0433\u043e\u0440\u044c\u0435\u0432\u0438\u0447 <\/strong>&#8212; \u043a\u0430\u043d\u0434.\u0444\u0430\u0440\u043c.\u043d\u0430\u0443\u043a, Ph.D., \u0441\u0435\u0440\u0442\u0438\u0444\u0438\u0446\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u044b\u0439 \u044d\u043a\u0441\u043f\u0435\u0440\u0442 \/ \u0430\u0443\u0434\u0438\u0442\u043e\u0440 \/ \u0442\u0440\u0435\u043d\u0435\u0440 GMP\/GDP, \u0438\u043d\u0441\u043f\u0435\u043a\u0442\u043e\u0440, \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u043d\u044b\u0439 PIC\\S<\/p>\n\n\n\n<p><strong>\u041e\u0441\u043d\u043e\u0432\u043d\u044b\u0435 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u044b \\ \u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0430:<\/strong><\/p>\n\n\n\n<ul><li>\u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 EU (EMA) 536\/2014\u043f\u043e \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u0438\u044e \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u0439 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u0434\u043b\u044f \u0447\u0435\u043b\u043e\u0432\u0435\u043a\u0430 \u2013 <em>Regulation (EU) No 536\/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and repealing Directive 2001\/20\/EC<\/em>;<\/li><li>\u043f\u0440\u0430\u0432\u0438\u043b\u0430 EU GMP \u0434\u043b\u044f IMP \u0432 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0438 \u0441 \u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442\u043e\u043c 536\/2014 \u2013 <em>Detailed Commission Guidelines on Good Manufacturing Practice for Investigational Medicinal Products for Human Use, Pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536\/2014, 08 December 2017<\/em>) \u2013 <em>EudraLex, Vol.4, Annex 13 \\ Vol.10, Chapter III Quality, Guidelines detailed<\/em>;<\/li><li>\u0414\u0435\u043b\u0435\u0433\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u044b\u0439 \u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 EU 2017\/1569, \u0434\u043e\u043f\u043e\u043b\u043d\u044f\u044e\u0449\u0438\u0439 \u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 No 536\/2014 \u0432 \u0447\u0430\u0441\u0442\u0438 \u043f\u0440\u0430\u0432\u0438\u043b GMP \u0434\u043b\u044f IMP \u0438 \u0432 \u043e\u0442\u043d\u043e\u0448\u0435\u043d\u0438\u0435 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440 \u0438\u043d\u0441\u043f\u0435\u043a\u0446\u0438\u0439 \u0434\u043b\u044f IMP \u2013 <em>Commission Delegated Regulation EU) 2017\/1569 of 23 May 2017 supplementing Regulation (EU) No 536\/2014 of the European Parliament and of the Council by Specifying Principles of and Guidelines for Good Manufacturing Practice for Investigational Medicinal Products for Human Use and Arrangements for Inspections<\/em>;<\/li><li>\u043f\u043e\u043b\u043e\u0436\u0435\u043d\u0438\u044f \u0432 \u043e\u0442\u0434\u0435\u043b\u044c\u043d\u044b\u0445 \u0420\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0430\u0445 EMA, \u0432\u0445\u043e\u0434\u044f\u0449\u0438\u0445 \u0432 \u0421\u0431\u043e\u0440\u043d\u0438\u043a\u0435 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440 \u0415\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u043a\u043e\u0433\u043e \u0421\u043e\u043e\u0431\u0449\u0435\u0441\u0442\u0432\u0430 \u043f\u043e \u0438\u043d\u0441\u043f\u0435\u043a\u0442\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u044e \u0438 \u043e\u0431\u043c\u0435\u043d\u0443 \u0438\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0438\u0435\u0439, \u043a\u0430\u0441\u0430\u044e\u0449\u0438\u0435\u0441\u044f \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u2013 <em>Compilation of Community Procedures on Inspections and Exchange of Information<\/em> (EMA\/369583\/2023);<\/li><li>\u043d\u043e\u0432\u044b\u0435 \u0441\u043f\u0435\u0446\u0438\u0430\u043b\u0438\u0437\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u044b\u0435 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 WHO GMP \u0434\u043b\u044f \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u2013 <em>Good Manufacturing Practices for Investigational Products<\/em> (<em>TRS No 1044<\/em>, <em>2022<\/em>);<\/li><li>\u043f\u0430\u043c\u044f\u0442\u043a\u0430 PIC\/S \u0434\u043b\u044f \u0438\u043d\u0441\u043f\u0435\u043a\u0442\u043e\u0440\u043e\u0432 \u0432 \u043e\u0442\u043d\u043e\u0448\u0435\u043d\u0438\u0435 \u043f\u0440\u0438\u043c\u0435\u043d\u0438\u043c\u043e\u0441\u0442\u0438 \u043f\u0440\u0430\u0432\u0438\u043b GMP \u0434\u043b\u044f \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432, \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u0443\u0435\u043c\u044b\u0445 \u0432 \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u044f\u0445 \u043d\u0430 \u043b\u044e\u0434\u044f\u0445 (\u0434\u043b\u044f \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432) \u2013 <em>Aide-Memoire. GMP Particularities in the Manufacture of Medicinal Products to be Used in Clinical Trials on Human Subjects <\/em>(<em>PI 022-2, 2007<\/em>);<\/li><li>\u0441\u043f\u0435\u0446\u0438\u0430\u043b\u0438\u0437\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u044b\u0435 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 US (FDA) cGMP \u0434\u043b\u044f IMP, \u043f\u0440\u0435\u0434\u043d\u0430\u0437\u043d\u0430\u0447\u0435\u043d\u043d\u044b\u0445 \u0434\u043b\u044f \u0444\u0430\u0437\u044b 1 \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u0439 \u2013 <em>Guidance for Industry. CGMP for Phase 1 Investigational Drugs <\/em>(<em>2008<\/em>).<\/li><\/ul>\n\n\n\n<p>\u0420\u0430\u0437\u0432\u0438\u0442\u0438\u0435 \u0440\u0435\u0433\u0443\u043b\u044f\u0442\u043e\u0440\u043d\u043e\u0439 \u0431\u0430\u0437\u044b \u0438 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u0439 \u0432 \u0441\u0444\u0435\u0440\u0435 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u043e\u0432 \u0432\u043a\u043b\u044e\u0447\u0430\u0435\u0442, \u0441\u0440\u0435\u0434\u0438 \u043f\u0440\u043e\u0447\u0435\u0433\u043e, \u0443\u0434\u0435\u043b\u0435\u043d\u0438\u0435 \u0432\u0441\u0435 \u0431\u043e\u043b\u044c\u0448\u0435\u0433\u043e \u0432\u043d\u0438\u043c\u0430\u043d\u0438\u044f \u043d\u0430\u0447\u0430\u043b\u044c\u043d\u044b\u043c \u0441\u0442\u0430\u0434\u0438\u044f\u043c \u0436\u0438\u0437\u043d\u0435\u043d\u043d\u043e\u0433\u043e \u0446\u0438\u043a\u043b\u0430 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432, \u0432 \u0442\u043e\u043c \u0447\u0438\u0441\u043b\u0435 \u043f\u043e\u0441\u0442\u0435\u043f\u0435\u043d\u043d\u043e\u0433\u043e \u0443\u0432\u0435\u043b\u0438\u0447\u0435\u043d\u0438\u044f \u0441\u0442\u0440\u043e\u0433\u043e\u0441\u0442\u0438 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043e\u0432 \u0432 \u043e\u0442\u043d\u043e\u0448\u0435\u043d\u0438\u0435 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u043e\u0432 \u043d\u0430 \u0441\u0442\u0430\u0434\u0438\u0438 \u043d\u0430\u0447\u0430\u043b\u044c\u043d\u043e\u0433\u043e \u043e\u0441\u0432\u043e\u0435\u043d\u0438\u044f \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u0441 \u0446\u0435\u043b\u044c\u044e \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u0438\u044f \u043e\u0431\u0440\u0430\u0437\u0446\u043e\u0432, \u043a\u043e\u0442\u043e\u0440\u044b\u0435 \u043c\u043e\u0433\u0443\u0442 \u0431\u044b\u0442\u044c \u043e\u0444\u0438\u0446\u0438\u0430\u043b\u044c\u043d\u043e \u043f\u0440\u0438\u0437\u043d\u0430\u043d\u043d\u044b\u043c\u0438 \u043a\u0430\u043a \u0442\u0430\u043a\u0438\u0435, \u043a\u043e\u0442\u043e\u0440\u044b\u0435 \u043f\u0440\u0438\u0435\u043c\u043b\u0435\u043c\u044b \u0438 \u043c\u043e\u0433\u0443\u0442 \u0431\u044b\u0442\u044c \u043f\u0440\u0438\u043c\u0435\u043d\u0435\u043d\u044b \u0434\u043b\u044f \u043e\u0431\u043e\u0441\u043d\u043e\u0432\u0430\u043d\u0438\u044f \u0438 \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u0438\u044f \u0434\u043e\u043a\u0430\u0437\u0430\u0442\u0435\u043b\u044c\u0441\u0442\u0432 \u0438\u0437 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0441\u0442\u0438 \u0438 \u044d\u0444\u0444\u0435\u043a\u0442\u0438\u0432\u043d\u043e\u0441\u0442\u0438 \u043d\u0430 \u043b\u044e\u0434\u044f\u0445. \u041f\u043e\u044d\u0442\u043e\u043c\u0443 \u043f\u043e\u043d\u0438\u043c\u0430\u043d\u0438\u0435 \u0434\u0430\u043d\u043d\u043e\u0433\u043e \u0432\u0435\u043a\u0442\u043e\u0440\u0430 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u043e\u0432 \u0432 \u0441\u0444\u0435\u0440\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u043f\u0440<em>\u0435\u0434\u0441\u0442\u0430\u0432\u043b\u044f\u0435\u0442\u0441\u044f \u0434\u043e\u0441\u0442\u0430\u0442\u043e\u0447\u043d\u043e \u0430\u043a\u0442\u0443\u0430\u043b\u044c\u043d\u044b\u043c \u0438 \u0432\u0430\u0436\u043d\u044b\u043c \u0434\u043b\u044f \u043f\u0440\u0430\u0432\u0438\u043b\u044c\u043d\u043e\u0433\u043e \u0438 \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0433\u043e \u0440\u0430\u0437\u0432\u0438\u0442\u0438\u044f \u043a\u0430\u043a \u0432\u0441\u0435\u0439 \u043e\u0442\u0440\u0430\u0441\u043b\u0438 \u0432 \u0446\u0435\u043b\u043e\u043c, \u0442\u0430\u043a \u0438 \u043e\u0442\u0434\u0435\u043b\u044c\u043d\u044b\u0445 \u043e\u043f\u0435\u0440\u0430\u0442\u043e\u0440\u043e\u0432 \\ \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u0439<\/em><\/p>\n\n\n\n<p><strong>\u0426\u0435\u043b\u0435\u0432\u0430\u044f \u0430\u0443\u0434\u0438\u0442\u043e\u0440\u0438\u044f:<\/strong>  \u0434\u043b\u044f \u0441\u043f\u0435\u0446\u0438\u0430\u043b\u0438\u0441\u0442\u043e\u0432 \u0438 \u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u043b\u0438\u0446 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u0435\u0439, \u0438\u043c\u043f\u043e\u0440\u0442\u0435\u0440\u043e\u0432 \u0438 \u0432\u043b\u0430\u0434\u0435\u043b\u044c\u0446\u0435 \u0442\u043e\u0440\u0433\u043e\u0432\u044b\u0445 \u043b\u0438\u0446\u0435\u043d\u0437\u0438\u0439 (\u0432\u043b\u0430\u0434\u0435\u043b\u044c\u0446\u0435\u0432 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u044b\u0445 \u0441\u0432\u0438\u0434\u0435\u0442\u0435\u043b\u044c\u0441\u0442\u0432 \u2013 MAHs) \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u0434\u043b\u044f \u0447\u0435\u043b\u043e\u0432\u0435\u043a\u0430 \u2013 \u0434\u043b\u044f \u0441\u043f\u0435\u0446\u0438\u0430\u043b\u0438\u0441\u0442\u043e\u0432 \u043f\u043e\u0434\u0440\u0430\u0437\u0434\u0435\u043b\u0435\u043d\u0438\u0439 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u043e\u0439 \u0440\u0430\u0437\u0440\u0430\u0431\u043e\u0442\u043a\u0438, \u0441\u043b\u0443\u0436\u0431\u044b \u043e\u0431\u0435\u0441\u043f\u0435\u0447\u0435\u043d\u0438\u044f \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430, \u0423\u043f\u043e\u043b\u043d\u043e\u043c\u043e\u0447\u0435\u043d\u043d\u044b\u0445 \u043b\u0438\u0446, \u043f\u043e\u0434\u0440\u0430\u0437\u0434\u0435\u043b\u0435\u043d\u0438\u0439 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432, \u0430 \u0442\u0430\u043a\u0436\u0435 \u0434\u043b\u044f \u0441\u043f\u0435\u0446\u0438\u0430\u043b\u0438\u0441\u0442\u043e\u0432 \u0440\u0435\u0433\u0443\u043b\u044f\u0442\u043e\u0440\u043d\u044b\u0445 \u0438 \u044d\u043a\u0441\u043f\u0435\u0440\u0442\u043d\u044b\u0445 \u043e\u0440\u0433\u0430\u043d\u043e\u0432 \u0432 \u0441\u0444\u0435\u0440\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u0434\u043b\u044f \u0447\u0435\u043b\u043e\u0432\u0435\u043a\u0430<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>\u0414<em>\u0430\u043d\u043d\u044b\u0439 \u0442\u0440\u0435\u043d\u0438\u043d\u0433 \u043f\u0440\u0435\u0434\u043f\u043e\u043b\u0430\u0433\u0430\u0435\u0442 \u043b\u0435\u043a\u0446\u0438\u043e\u043d\u043d\u044b\u0439 \u043c\u0430\u0442\u0435\u0440\u0438\u0430\u043b \u043f\u043e \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c \u0432 \u0440\u0430\u043c\u043a\u0430\u0445 \u043f\u0440\u0438\u043d\u044f\u0442\u044b\u0445 \u0438 \u043f\u0440\u0438\u0437\u043d\u0430\u0432\u0430\u0435\u043c\u044b\u0445 \u043c\u0435\u0436\u0434\u0443\u043d\u0430\u0440\u043e\u0434\u043d\u044b\u0445 \u0420\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432 \u0432 \u043e\u0442\u043d\u043e\u0448\u0435\u043d\u0438\u0438 \u043f\u0440\u0438\u043c\u0435\u043d\u0435\u043d\u0438\u044f \u043f\u0440\u0430\u0432\u0438\u043b \u043d\u0430\u0434\u043b\u0435\u0436\u0430\u0449\u0435\u0433\u043e \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 (GMP) \u0434\u043b\u044f \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 (IMP) \u0434\u043b\u044f \u0447\u0435\u043b\u043e\u0432\u0435\u043a\u0430<\/em><\/p>\n\n\n\n<h2 class=\"has-text-align-center\"><strong>\u041f\u0440\u043e\u0433\u0440\u0430\u043c\u043c\u0430<\/strong><\/h2>\n\n\n\n<ul><li>\u0412\u0432\u0435\u0434\u0435\u043d\u0438\u0435 \u0432 \u041f\u0440\u043e\u0433\u0440\u0430\u043c\u043c\u0443<\/li><li>\u0418\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0435 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0435 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 (<em>IMP \u2013 Investigational Medicinal Products \\\\ (IND \u2013 Investigational New Drugs<\/em>) \u2013 \u0441\u043e\u0432\u0440\u0435\u043c\u0435\u043d\u043d\u043e\u0435 \u043f\u043e\u043d\u044f\u0442\u0438\u0435 \u043f\u043e\u043d\u044f\u0442\u0438\u044f<\/li><li>\u041e\u0441\u043d\u043e\u0432\u043d\u044b\u0435 \u043c\u0435\u0436\u0434\u0443\u043d\u0430\u0440\u043e\u0434\u043d\u044b\u0435 \u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0430 \u043f\u043e \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0443 \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u2013 \u0438\u0445 \u0444\u043e\u0440\u043c\u0430\u0442\u044b, \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435, \u043d\u0430\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u043d\u043e\u0441\u0442\u044c \u0438 \u043f\u0440\u0438\u043c\u0435\u043d\u0438\u043c\u043e\u0441\u0442\u044c<\/li><li>\u041f\u043e\u043d\u044f\u0442\u0438\u0435 \u0424\u0430\u0439\u043b\u0430 (\u0434\u043e\u0441\u044c\u0435) \u0441\u043f\u0435\u0446\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u043e\u0433\u043e \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430 (<em>PSF \u2013 <\/em><em>Product <\/em><em>Specification <\/em><em>File<\/em>) \u043a\u0430\u043a GMP-\u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430, \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u0435 \u0432 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0438 \u0441 \u0441\u043e\u0432\u0440\u0435\u043c\u0435\u043d\u043d\u044b\u043c\u0438 \u0420\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0430\u043c\u0438 EU (EMA), PIC\/S, WHO<\/li><li>\u0421\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u044f \u0441\u0435\u0440\u0438\u0438 \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u043e\u0433\u043e \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 \u0423\u043f\u043e\u043b\u043d\u043e\u043c\u043e\u0447\u0435\u043d\u043d\u044b\u043c \\ \u0410\u0432\u0442\u043e\u0440\u0438\u0437\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u044b\u043c \u043b\u0438\u0446\u043e\u043c \u043f\u0440\u0438 \u0435\u0435 \u0432\u044b\u043f\u0443\u0441\u043a\u0435 (<em>Release <\/em><em>of <\/em><em>Beaches<\/em>) \u0434\u043b\u044f \u043f\u043e\u0441\u0442\u0430\u0432\u043e\u043a \u0434\u043b\u044f \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u0439 \u0438 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f \u043a QP \\ AP<\/li><li>\u0421\u043f\u0435\u0446\u0438\u0444\u0438\u0447\u043d\u044b\u0435 \u0430\u0441\u043f\u0435\u043a\u0442\u044b \u0432\u0441\u0435\u0445 \u043e\u0441\u043d\u043e\u0432\u043d\u044b\u0445 \u0440\u0430\u0437\u0434\u0435\u043b\u043e\u0432 \u043f\u0440\u0430\u0432\u0438\u043b GMP IMP: \u043f\u0435\u0440\u0441\u043e\u043d\u0430\u043b, \u043f\u043e\u043c\u0435\u0449\u0435\u043d\u0438\u044f \u0438 \u043e\u0431\u043e\u0440\u0443\u0434\u043e\u0432\u0430\u043d\u0438\u0435, \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430\u0446\u0438\u044f \u0434\u043b\u044f \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0430 IMP, \u0437\u0430\u043a\u0430\u0437 \u0441\u043f\u043e\u043d\u0441\u043e\u0440\u0430 (<em>Order<\/em>), \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0439 \u043f\u0440\u043e\u0446\u0435\u0441\u0441 \u0438 \u043f\u043e\u043d\u044f\u0442\u0438\u0435 <em>Pilot <\/em><em>Scale <\/em><em>Batch<\/em>, \u043f\u043e\u043d\u044f\u0442\u0438\u0435 \u043e\u043f\u0435\u0440\u0430\u0446\u0438\u0438 \u00ab\u043e\u0441\u043b\u0435\u043f\u043b\u0435\u043d\u0438\u044f\u00bb (<em>Blinding <\/em><em>operations<\/em>), \u043c\u043e\u0434\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u044f \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u043e\u0432 \u0441\u0440\u0430\u0432\u043d\u0435\u043d\u0438\u044f (<em>Modification <\/em><em>of <\/em><em>comparator <\/em><em>products<\/em>), \u043f\u0440\u043e\u0446\u0435\u0441\u0441 \u0443\u043f\u0430\u043a\u043e\u0432\u043a\u0438 \u0438 \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u0438 IMP, \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044c \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430 \u0438 \u043e\u0431\u0440\u0430\u0449\u0435\u043d\u0438\u0435 \u0441 \u0441\u043e\u0445\u0440\u0430\u043d\u044f\u0435\u043c\u044b\u043c\u0438 \u043e\u0431\u0440\u0430\u0437\u0446\u0430\u043c\u0438 (<em>Retention <\/em><em>of <\/em><em>samples <\/em><em>used <\/em><em>for <\/em><em>quality <\/em><em>control<\/em>), \u043f\u043e\u0441\u0442\u0430\u0432\u043a\u0438 IMP, \u043a\u0432\u0430\u043b\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u044f \u0438 \u0432\u0430\u043b\u0438\u0434\u0430\u0446\u0438\u044f \u043f\u0440\u0438 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435 IMP, \u043f\u043e\u0441\u0442\u0430\u0432\u043a\u0438 (<em>Shipping<\/em>), \u0440\u0435\u043a\u043b\u0430\u043c\u0430\u0446\u0438\u0438, \u0432\u043e\u0437\u0432\u0440\u0430\u0442\u044b \u0438 \u043e\u0442\u0437\u044b\u0432\u044b \u043f\u0440\u0438\u043c\u0435\u043d\u0438\u043c\u043e \u043a IMP, \u0443\u043d\u0438\u0447\u0442\u043e\u0436\u0435\u043d\u0438\u0435 (<em>Destruction<\/em>)<\/li><li>\u0421\u043f\u0435\u0446\u0438\u0444\u0438\u043a\u0430 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u0439 \u043a \u0441\u043e\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u044e \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043e\u043a IMP \u0432 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0438 \u0441 \u043f\u0440\u0430\u0432\u0438\u043b\u0430\u043c\u0438 GMP IMP \u0438 \u0441\u043e\u0432\u0440\u0435\u043c\u0435\u043d\u043d\u044b\u043c\u0438 \u043c\u0435\u0436\u0434\u0443\u043d\u0430\u0440\u043e\u0434\u043d\u044b\u043c\u0438 \u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0430\u043c\u0438 (<em>Regulation <\/em><em>EU<\/em>)<\/li><li>\u041a\u043e\u043d\u0442\u0440\u043e\u043b\u044c\u043d\u044b\u0435 \u0438\u043d\u0441\u043f\u0435\u043a\u0446\u0438\u043e\u043d\u043d\u044b\u0435 \u0432\u043e\u043f\u0440\u043e\u0441\u044b \u043f\u0440\u0438 \u043e\u0446\u0435\u043d\u043a\u0435 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432 \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u043d\u0430 \u043e\u0441\u043d\u043e\u0432\u0435 \u0434\u0435\u0439\u0441\u0442\u0432\u0443\u044e\u0449\u0438\u0445 \u0440\u0435\u043a\u043e\u043c\u0435\u043d\u0434\u0430\u0446\u0438\u0439 PIC\\S (\u043f\u043e \u0440\u0430\u0437\u0434\u0435\u043b\u0430\u043c GMP IMP)<\/li><li><em>\u041c\u0438\u043d\u0438-\u0442\u0440\u0435\u043d\u0438\u043d\u0433\u0438 \u043f\u043e \u0445\u043e\u0434\u0443 \u0441\u0435\u043c\u0438\u043d\u0430\u0440\u0430<\/em><\/li><li>\u0414\u0438\u0441\u043a\u0443\u0441\u0441\u0438\u0438 \u0438 \u043e\u0431\u0441\u0443\u0436\u0434\u0435\u043d\u0438\u0435 \u0432\u043e\u0437\u043d\u0438\u043a\u0430\u044e\u0449\u0438\u0445 \u0432\u043e\u043f\u0440\u043e\u0441\u043e\u0432 \u043f\u043e \u0445\u043e\u0434\u0443 \u043f\u0440\u043e\u0433\u0440\u0430\u043c\u043c\u044b. \u0417\u0430\u0432\u0435\u0440\u0448\u0435\u043d\u0438\u0435 \u043f\u0440\u043e\u0433\u0440\u0430\u043c\u043c\u044b<\/li><\/ul>\n\n\n\n<p>\ud83d\udcb0<strong> \u0421\u0442\u043e\u0438\u043c\u043e\u0441\u0442\u044c \u0443\u0447\u0430\u0441\u0442\u0438\u044f:<\/strong><br><strong>\ud83d\udd39 245 $ <\/strong>\u043f\u0440\u0438 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 <strong>\u0434\u043e 30 \u0430\u043f\u0440\u0435\u043b\u044f<\/strong><br>\ud83d\udc65<strong>60 $ <\/strong>\u2013 2-\u0439 \u0438 \u043a\u0430\u0436\u0434\u044b\u0439 \u0441\u043b\u0435\u0434\u0443\u044e\u0449\u0438\u0439 \u0443\u0447\u0430\u0441\u0442\u043d\u0438\u043a<\/p>\n\n\n\n<p>\ud83d\udd39 <strong>270 $<\/strong> \u043f\u0440\u0438 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 <strong>\u043f\u043e\u0441\u043b\u0435 30 \u0430\u043f\u0440\u0435\u043b\u044f<\/strong><br>\ud83d\udc65<strong> 70 $  <\/strong>\u2013 2-\u0439 \u0438 \u043a\u0430\u0436\u0434\u044b\u0439 \u0441\u043b\u0435\u0434\u0443\u044e\u0449\u0438\u0439 \u0443\u0447\u0430\u0441\u0442\u043d\u0438\u043a<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u0412\u0440\u0435\u043c\u044f \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u0438\u044f:&nbsp;10.00 \u2013 13.00 \u043f\u043e \u043a\u0438\u0435\u0432\u0441\u043a\u043e\u043c\u0443 \u0432\u0440\u0435\u043c\u0435\u043d\u0438 \u0410\u0432\u0442\u043e\u0440 \u0438 \u0432\u0435\u0434\u0443\u0449\u0438\u0439: \u041d\u0438\u043a\u0438\u0442\u044e\u043a \u0412\u0430\u043b\u0435\u0440\u0438\u0439 \u0413\u0440\u0438\u0433\u043e\u0440\u044c\u0435\u0432\u0438\u0447 &#8212; \u043a\u0430\u043d\u0434.\u0444\u0430\u0440\u043c.\u043d\u0430\u0443\u043a, Ph.D., \u0441\u0435\u0440\u0442\u0438\u0444\u0438\u0446\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u044b\u0439 \u044d\u043a\u0441\u043f\u0435\u0440\u0442 \/ \u0430\u0443\u0434\u0438\u0442\u043e\u0440 \/ \u0442\u0440\u0435\u043d\u0435\u0440 GMP\/GDP, \u0438\u043d\u0441\u043f\u0435\u043a\u0442\u043e\u0440, \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u043d\u044b\u0439 PIC\\S \u041e\u0441\u043d\u043e\u0432\u043d\u044b\u0435 \u043d\u043e\u0440\u043c\u0430\u0442\u0438\u0432\u044b \\ \u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0430: \u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 EU (EMA) 536\/2014\u043f\u043e \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u0438\u044e \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u0439 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432 \u0434\u043b\u044f \u0447\u0435\u043b\u043e\u0432\u0435\u043a\u0430 \u2013 Regulation (EU) No 536\/2014 of the European Parliament and of the Council of<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"single-events.php","format":"standard","meta":[],"categories":[36,7],"tags":[1404,1405],"translation":{"provider":"WPGlobus","version":"3.0.1","language":"ru","enabled_languages":["ua","ru"],"languages":{"ua":{"title":true,"content":true,"excerpt":false},"ru":{"title":true,"content":true,"excerpt":false}}},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u041f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u043e \u0438\u0441\u0441\u043b\u0435\u0434\u0443\u0435\u043c\u044b\u0445 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u0441\u0440\u0435\u0434\u0441\u0442\u0432(IMP \u2013 Investigational Medicinal Products) \u2013\u041f\u043e\u043d\u044f\u0442\u0438\u044f \u0438 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