{"id":301371,"date":"2026-11-03T14:06:22","date_gmt":"2026-11-03T14:06:22","guid":{"rendered":"https:\/\/www.merieuxnutrisciences.com\/?post_type=events&#038;p=301371"},"modified":"2026-11-05T13:41:20","modified_gmt":"2026-11-05T13:41:20","slug":"free-webinar-extractables-leachables-in-practice-ich-q3e-usp-665-and-risk-based-assessment","status":"publish","type":"events","link":"https:\/\/www.merieuxnutrisciences.com\/it\/events\/free-webinar-extractables-leachables-in-practice-ich-q3e-usp-665-and-risk-based-assessment\/","title":{"rendered":"Free webinar | Extractables &amp; Leachables in practice: ICH Q3E, USP &lt;665> and risk-based assessment"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gli studi di Extractables &amp; Leachables (E&amp;L) sono essenziali per valutare la sicurezza e la compatibilit\u00e0 di packaging, delivery systems e componenti di processo. Per definire una strategia efficace, le aziende hanno dovuto a lungo orientarsi tra requisiti normativi, indicazioni delle linee guida e aspettative del settore, spesso frammentati.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Oggi la situazione sta evolvendo. La bozza della linea guida ICH Q3E introduce un quadro integrato per la valutazione e il controllo degli E&amp;L, mentre il capitolo USP &lt;665&gt; propone un approccio risk-based per i componenti e i sistemi in plastica utilizzati nei processi di produzione farmaceutici e biofarmaceutici.<\/p>\n\n\n\n<div class=\"wp-block-columns are-vertically-aligned-center has-theme-palette-7-background-color has-background is-layout-flex wp-container-core-columns-is-layout-5b0bc1de wp-block-columns-is-layout-flex\" style=\"border-top-left-radius:8px;border-top-right-radius:8px;border-bottom-left-radius:8px;border-bottom-right-radius:8px;padding-top:var(--wp--preset--spacing--50);padding-right:var(--wp--preset--spacing--50);padding-bottom:var(--wp--preset--spacing--50);padding-left:var(--wp--preset--spacing--50)\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong><strong>Extractables &amp; Leachables in practice: ICH Q3E, USP &lt;665&gt; and risk-based assessment<\/strong><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n<style>.wp-block-kadence-iconlist.kt-svg-icon-list-items301369_48370e-7a:not(.this-stops-third-party-issues){margin-top:0px;margin-bottom:0px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items301369_48370e-7a ul.kt-svg-icon-list:not(.this-prevents-issues):not(.this-stops-third-party-issues):not(.tijsloc){margin-top:0px;margin-right:0px;margin-bottom:var(--global-kb-spacing-sm, 1.5rem);margin-left:0px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items301369_48370e-7a ul.kt-svg-icon-list{grid-row-gap:5px;}.wp-block-kadence-iconlist.kt-svg-icon-list-items301369_48370e-7a ul.kt-svg-icon-list .kt-svg-icon-list-item-wrap .kt-svg-icon-list-single{margin-right:10px;}.kt-svg-icon-list-items301369_48370e-7a ul.kt-svg-icon-list .kt-svg-icon-list-level-0 .kt-svg-icon-list-single svg{font-size:20px;}<\/style>\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items301369_48370e-7a kt-svg-icon-list-columns-1 alignnone\"><ul class=\"kt-svg-icon-list\"><style>.kt-svg-icon-list-item-301369_43b0fb-ce .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-301369_43b0fb-ce\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_calendar kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><rect x=\"3\" y=\"4\" width=\"18\" height=\"18\" rx=\"2\" ry=\"2\"\/><line x1=\"16\" y1=\"2\" x2=\"16\" y2=\"6\"\/><line x1=\"8\" y1=\"2\" x2=\"8\" y2=\"6\"\/><line x1=\"3\" y1=\"10\" x2=\"21\" y2=\"10\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\">3 Dicembre 2026<\/span><\/li>\n\n\n<style>.kt-svg-icon-list-item-301369_af7dc0-da .kt-svg-icon-list-text mark.kt-highlight{background-color:unset;font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}<\/style>\n<li class=\"wp-block-kadence-listitem kt-svg-icon-list-item-wrap kt-svg-icon-list-item-301369_af7dc0-da\"><span class=\"kb-svg-icon-wrap kb-svg-icon-fe_clock kt-svg-icon-list-single\"><svg viewBox=\"0 0 24 24\"  fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"  aria-hidden=\"true\"><circle cx=\"12\" cy=\"12\" r=\"10\"\/><polyline points=\"12 6 12 12 16 14\"\/><\/svg><\/span><span class=\"kt-svg-icon-list-text\">11:00am &#8211; 12:00pm CET<\/span><\/li>\n<\/ul><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full has-custom-border is-style-rounded\"><img loading=\"lazy\" decoding=\"async\" width=\"3556\" height=\"2000\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/09\/shutterstock_744413632_Extractables-and-leachables.jpg\" alt=\"Extractables-and-leachables\" class=\"wp-image-113125\" style=\"border-style:none;border-width:0px;border-top-left-radius:4px;border-top-right-radius:4px;border-bottom-left-radius:4px;border-bottom-right-radius:4px\"\/><\/figure>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div style=\"--wp--block-button--width: 100;\" class=\"wp-block-button has-custom-width wp-block-button__width wp-block-button__width-100\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/attendee.gotowebinar.com\/register\/2879548844568666454?source=Sito\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Registrati gratuitamente<\/strong><\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Durante il webinar approfondiremo i seguenti temi.<br>\u2022 Il quadro attuale dei requisiti normativi e delle linee guida in materia di E&amp;L<br>\u2022 Ambito di applicazione e principi chiave della bozza della linea guida ICH Q3E e del capitolo USP &lt;665&gt;<br>\u2022 Come il risk assessment pu\u00f2 orientare l\u2019ampiezza e il disegno degli studi E&amp;L<br>\u2022 Le relazioni tra packaging, delivery systems e manufacturing components<br>\u2022 Aspetti pratici per adeguare le strategie E&amp;L all\u2019evoluzione delle aspettative<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>La relatrice<br><\/strong>Margherita Monico \u00e8 E&amp;L Senior Project Manager presso M\u00e9rieux NutriSciences, dove progetta e supervisiona studi di Extractables &amp; Leachables. Si \u00e8 laureata in Medicina veterinaria all\u2019Universit\u00e0 di Padova e ha conseguito un Master in Biotechnology for Business presso CUOA Business School. Tiene regolarmente corsi su misura e webinar sugli E&amp;L.<\/p>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-301369_189412-7e .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-301369_189412-7e .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-301369_189412-7e\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><hr class=\"kt-divider\"\/><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"featured_media":113123,"template":"","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":""},"eventstax":[1984,166],"class_list":["post-301371","events","type-events","status-publish","has-post-thumbnail","hentry","eventstax-pharma-healthcare","eventstax-webinar-it"],"acf":[],"taxonomy_info":{"eventstax":[{"value":1984,"label":"Pharma &amp; Healthcare"},{"value":166,"label":"Webinar"}]},"featured_image_src_large":["https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/09\/shutterstock_744413632_Extractables-and-leachables.jpg",1024,576,false],"author_info":[],"comment_info":"","_links":{"self":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/events\/301371","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/events"}],"about":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/types\/events"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/media\/113123"}],"wp:attachment":[{"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/media?parent=301371"}],"wp:term":[{"taxonomy":"eventstax","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/it\/wp-json\/wp\/v2\/eventstax?post=301371"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}