{"id":2467,"date":"2023-10-09T16:22:46","date_gmt":"2023-10-09T14:22:46","guid":{"rendered":"https:\/\/jjpbiologics.com\/?p=2467"},"modified":"2023-11-09T17:29:20","modified_gmt":"2023-11-09T15:29:20","slug":"zapytanie-z-dnia-09-10-2023","status":"publish","type":"post","link":"https:\/\/jjpbiologics.com\/pl\/zapytanie-z-dnia-09-10-2023\/","title":{"rendered":"Zapytanie z dnia 09\/10\/2023"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2467\" class=\"elementor elementor-2467\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t<div class=\"elementor-inner\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a6c4773 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a6c4773\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t\t\t<div class=\"elementor-row\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4540d693 sc_inner_width_none sc_layouts_column_icons_position_left\" data-id=\"4540d693\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-column-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-546d1720 elementor-widget elementor-widget-text-editor\" data-id=\"546d1720\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-text-editor elementor-clearfix\"><p><span dir=\"ltr\" style=\"font-size: 16px;\"> 2310_T01_DLY_01 QP<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\">W zwi\u0105zku z realizacj\u0105 projektu rozwoju kandydata na lek o tytule \u201eDevelopment of first-in-class antibody therapy for treatment of the ultra-rare LABD indication as well as for pulmonary and autoimmune diseases with IgA mediated pathology, using Companion Diagnostics (CDx) patient stratification for treatment with the JJP-1212&#8243; w ramach konkursu Rozw\u00f3j medycyny celowanej lub personalizowanej na bazie terapii kom\u00f3rkowych lub produkt\u00f3w bia\u0142kowych, organizowanego przez Agencj\u0119 Bada\u0144 Medycznych, og\u0142aszamy zapytanie ofertowe na realizacj\u0119 <strong>us\u0142ugi Qualified Person w celu wsparcia procesu opracowywania lek\u00f3w w programie terapeutycznego przeciwcia\u0142a monoklonalnego JJP-1212<\/strong><\/span><b>&nbsp;(ang. Qualified Person services to support the drug development process in JJP-1212 therapeutic monoclonal antibody program<\/b><b>).<\/b><\/li>\n<li style=\"font-size: 16px;\">Szczeg\u00f3\u0142y zapytania zostan\u0105 przekazane ka\u017cdorazowo po podpisaniu umowy o zachowaniu poufno\u015bci, w terminie 2 dni, lub po zg\u0142oszeniu si\u0119 podmiotu z&nbsp;aktywn\u0105 umow\u0105 o zachowaniu poufno\u015bci. Wz\u00f3r umowy do pobrania&nbsp;<a style=\"font-size: 16px; background-color: #ffffff;\" href=\"https:\/\/jjpbiologics.com\/wp-content\/uploads\/2022\/12\/CONFIDENTIALITY-AGREEMENT.docx\">LINK<\/a><span style=\"font-size: 16px;\">.<\/span><\/li>\n<li style=\"font-size: 16px;\"><del><span style=\"font-size: 16px;\">Termin sk\u0142adania ofert: 18.10.2023.<\/span><\/del><\/li>\n<li><span style=\"font-size: 16px;\">Termin sk\u0142adania ofert zosta\u0142 wyd\u0142u\u017cony do: <b>20.10.2023<\/b><\/span><\/li>\n<li><span style=\"font-size: 16px;\">Pytania i kontakt tw zwi\u0105zku z zapytaniem prosz\u0119 kierowa\u0107 na adres:&nbsp;<\/span><img decoding=\"async\" style=\"font-family: inherit; font-style: inherit; font-weight: inherit;\" src=\"data:image\/png;base64,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\" alt=\"\"><img decoding=\"async\" style=\"font-family: inherit; 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margin-bottom: 7px;\"><b>Zapytanie zosta\u0142o anulowane.<\/b><\/li>\n<\/ul>\n<p><span style=\"font-family: Hind, sans-serif; font-size: 15px; font-style: normal; font-weight: 400;\">Otrzymane pytania dotycz\u0105ce specyfikacji zam\u00f3wienia:<\/span><\/p>\n<ol>\n<li style=\"font-size: 15px; margin-top: 0px;\">It seems like the product will be released through your MIA. Can I ask where is it located?<br><b style=\"margin-bottom: 0px;\">Odpowied\u017a:<\/b>&nbsp;if MIA refers to Manufacturer\u2019s\/Importation Authorization, then production facility (CDMO) is located in Germany and headquarter of CDMO is in Switzerland. Supply chain vendor (which will perform relabelling for clinical purposes) has also MIA and is located in Poland.<\/li>\n<li style=\"font-size: 15px; margin-bottom: 7px;\">Is on site presence of QP required in this case?<br><b>Odpowied\u017a:&nbsp;<\/b>CDMO will deliver certification of DS and DP. Thus, on site presence of QP probably is not required to perform batch release, however this is QP discretion.<\/li>\n<\/ol><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>2310_T01_DLY_01 QP W zwi\u0105zku z realizacj\u0105 projektu rozwoju kandydata na lek o tytule \u201eDevelopment of first-in-class antibody therapy for treatment&hellip;<\/p>","protected":false},"author":990005,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"elementor_theme","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[64],"tags":[62],"class_list":["post-2467","post","type-post","status-publish","format-standard","hentry","category-zapytania","tag-jjp1212"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - 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Qualified Person services to support the drug development process in JJP-1212 therapeutic monoclonal antibody program<\/b><b>).<\/b><\/li>\n<li style=\"font-size: 16px\">Szczeg\u00f3\u0142y zapytania zostan\u0105 przekazane ka\u017cdorazowo po podpisaniu umowy o zachowaniu poufno\u015bci, w terminie 2 dni, lub po zg\u0142oszeniu si\u0119 podmiotu z&nbsp;aktywn\u0105 umow\u0105 o zachowaniu poufno\u015bci. Wz\u00f3r umowy do pobrania&nbsp;<a style=\"font-size: 16px;background-color: #ffffff\" href=\"https:\/\/jjpbiologics.com\/wp-content\/uploads\/2022\/12\/CONFIDENTIALITY-AGREEMENT.docx\">LINK<\/a>.<\/li>\n<li style=\"font-size: 16px\"><del>Termin sk\u0142adania ofert: 18.10.2023.<\/del><\/li>\n<li>Termin sk\u0142adania ofert zosta\u0142 wyd\u0142u\u017cony do: <b>20.10.2023<\/b><\/li>\n<li>Pytania i kontakt tw zwi\u0105zku z zapytaniem prosz\u0119 kierowa\u0107 na adres:&nbsp;<img style=\"font-family: inherit;font-style: inherit;font-weight: inherit\" src=\"image\/png;base64,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\" alt=\"\"><img style=\"font-family: inherit;font-style: inherit;font-weight: inherit\" 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alt=\"\"><img style=\"font-family: inherit;font-style: inherit;font-weight: inherit\" 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alt=\"\"><\/li>\n<li style=\"font-size: 16px;margin-bottom: 7px\"><b>Zapytanie zosta\u0142o anulowane.<\/b><\/li>\n<\/ul>\n<p>Otrzymane pytania dotycz\u0105ce specyfikacji zam\u00f3wienia:<\/p>\n<ol>\n<li style=\"font-size: 15px;margin-top: 0px\">It seems like the product will be released through your MIA. Can I ask where is it located?<br \/><b style=\"margin-bottom: 0px\">Odpowied\u017a:<\/b>&nbsp;if MIA refers to Manufacturer\u2019s\/Importation Authorization, then production facility (CDMO) is located in Germany and headquarter of CDMO is in Switzerland. Supply chain vendor (which will perform relabelling for clinical purposes) has also MIA and is located in Poland.<\/li>\n<li style=\"font-size: 15px;margin-bottom: 7px\">Is on site presence of QP required in this case?<br \/><b>Odpowied\u017a:&nbsp;<\/b>CDMO will deliver certification of DS and DP. Thus, on site presence of QP probably is not required to perform batch release, however this is QP discretion.<\/li>\n<\/ol>\n","comment_info":"No Comments","_links":{"self":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts\/2467","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/users\/990005"}],"replies":[{"embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/comments?post=2467"}],"version-history":[{"count":0,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts\/2467\/revisions"}],"wp:attachment":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/media?parent=2467"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/categories?post=2467"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/tags?post=2467"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}