Webinar | Orphan Drug Designation

<!doctype html><html lang="en-us"><head> <meta charset="utf-8"> <title>Webinar | Orphan Drug Designation</title> <link rel="shortcut icon" href="https://www.veristat.com/hubfs/favicon.ico"> <meta name="description" content="Regulatory experts working with the FDA, EMA, MHRA and Swissmedic share experiences navigating the requirements and nuances of ODD applications. "> <meta name="viewport" content="width=device-width, initial-scale=1"> <script src="/hs/hsstatic/jquery-libs/static-1.1/jquery/jquery-1.7.1.js"></script> <script>hsjQuery = window['jQuery'];</script> <meta property="og:description" content="Regulatory experts working with the FDA, EMA, MHRA and Swissmedic share experiences navigating the requirements and nuances of ODD applications. "> <meta property="og:title" content="Webinar | Orphan Drug Designation"> <meta name="twitter:description" content="Regulatory experts working with the FDA, EMA, MHRA and Swissmedic share experiences navigating the requirements and nuances of ODD applications. "> <meta name="twitter:title" content="Webinar | Orphan Drug Designation"> <style> a.cta_button{-moz-box-sizing:content-box !important;-webkit-box-sizing:content-box !important;box-sizing:content-box !important;vertical-align:middle}.hs-breadcrumb-menu{list-style-type:none;margin:0px 0px 0px 0px;padding:0px 0px 0px 0px}.hs-breadcrumb-menu-item{float:left;padding:10px 0px 10px 10px}.hs-breadcrumb-menu-divider:before{content:'›';padding-left:10px}.hs-featured-image-link{border:0}.hs-featured-image{float:right;margin:0 0 20px 20px;max-width:50%}@media (max-width: 568px){.hs-featured-image{float:none;margin:0;width:100%;max-width:100%}}.hs-screen-reader-text{clip:rect(1px, 1px, 1px, 1px);height:1px;overflow:hidden;position:absolute !important;width:1px} </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63712159645/1726675697504/VERISTAT-CLEAN-2022/css/main-head.css"> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63712050360/1732158771693/VERISTAT-CLEAN-2022/css/main-foot.min.css"> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63711874203/1726675694524/VERISTAT-CLEAN-2022/css/modules/global-header-v2.min.css"> <style> /******************************* MAIN DESKTOP NAV STYLE *******************************/ .hhs-top-bar { background-color: rgba(249, 249, 249, 1); padding: 12px 0; } .hhs-top-bar.sticky-menu.active { padding: 12px 0; } /* LOGOS */ .hhs-top-bar.hhs-alt-nav .logo-sticky, .logo-standard { max-width: 220px; float: left; } .hhs-top-bar.hhs-alt-nav.sticky-menu.active .logo-sticky, .logo-sticky { max-width: 240px; float: left; } .hhs-header-logo { padding-top: 0px; } /* MENU STYLE */ .hhs-nav-grid__menu { margin: 0 auto; } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a, .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links .hs-menu-item a { color: rgba(74, 74, 74, 1.0); } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li { margin: 15px 10px; } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links .hs-menu-item a:hover, .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-header-search a i:hover, .hhs-lang-switch .globe_class:hover{ color: rgba(153, 153, 153, 1.0); } .hhs-header-search a i{ color: rgba(74, 74, 74, 1); } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1.active:after, .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1:after { background-color: rgba(242, 245, 248, 1.0); } /* LANGUAGE SWITCHER */ .hhs-lang-switch .globe_class:before{ color: rgba(74, 74, 74, 1); } .lang_list_class li { background: rgba(0, 102, 51, 1) !important; } .hhs-lang-switch .lang_list_class:after { border-bottom-color: rgba(0, 102, 51, 1) !important; } /* STANDARD DROP DOWN MENU */ .hhs-hat-menu .hs-menu-children-wrapper, .sc-site-header__menu .hs-menu-children-wrapper { background-color: #006633; } .hhs-hat-menu .hs-menu-children-wrapper:before, .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper:before { color: rgba(0, 102, 51, 1) !important; } .hhs-hat-menu .hs-menu-children-wrapper li a, .hhs-lang-switch .lang_list_class li a, .custom-menu-primary .hs-menu-wrapper > ul li a, .hs-menu-wrapper.hs-menu-flow-horizontal > ul li.hs-item-has-children ul.hs-menu-children-wrapper li a, .hhs-lang-switch .lang_list_class li a { color: #FFFFFF; font-size: 16px !important; } .hhs-hat-menu .hs-menu-children-wrapper li a:hover, .hhs-lang-switch .lang_list_class li a:hover, .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links .hs-menu-item.hs-menu-depth-2 a:hover, .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a:hover, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links ul .hs-menu-item.sub-active a{ background-color: #9CCD4E; } .hhs-hat-menu .hs-menu-children-wrapper li a:hover, .hhs-lang-switch .lang_list_class li a:hover, .custom-menu-primary .hs-menu-wrapper > ul li.hs-item-has-children ul.hs-menu-children-wrapper li a:hover, .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links .hs-menu-item.hs-menu-depth-2 a:hover, .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a:hover, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links ul .hs-menu-item.sub-active a{ color: #fff !important; } .custom-menu-primary .hs-menu-wrapper > ul li.hs-item-has-children ul.hs-menu-children-wrapper li.active a:hover { color: #FFFFFF !important; } /* STICKY & ALT HEADER */ .hhs-top-bar.hhs-alt-nav.sticky-menu, .hhs-top-bar.sticky-menu, .hhs-top-bar.hhs-alt-nav{ background-color: rgba(255, 255, 255, 0.90); } .sticky-menu.active { background-color: rgba(255, 255, 255, 0.90); } .hhs-top-bar.sticky-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links .hs-menu-item a, .hhs-top-bar.hhs-alt-nav .hhs-header-search a i, .hhs-top-bar.hhs-alt-nav .fas, .hhs-top-bar.hhs-alt-nav .hhs-lang-switch .globe_class:before, .sticky-menu .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links li a, .sticky-menu .hhs-nav-grid__extras i, .sticky-menu .hhs-lang-switch .globe_class:before{ color: rgba(68, 68, 68, 1.0); } .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links ul .hs-menu-item a { color: #FFFFFF; } .hhs-top-bar.sticky-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-top-bar.hhs-alt-nav .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal .hs-menu-depth-1:first-child:hover, .hhs-top-bar.hhs-alt-nav .hhs-header-search a i:hover, .hhs-top-bar.hhs-alt-nav .fas:hover, .hhs-top-bar.hhs-alt-nav .hhs-lang-switch .globe_class:before, .sticky-menu .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal .hs-menu-depth-1:first-child:hover, .sticky-menu .hs-menu-wrapper.hs-menu-flow-horizontal ul.hhs-nav-links li a:hover, .sticky-menu .hhs-header-search a i:hover{ color: rgba(0, 0, 0, 1.0); } .hhs-top-bar.hhs-alt-nav .hhs-header-search a i, .hhs-top-bar.hhs-alt-nav .globe_class { color: rgba(68, 68, 68, 1) !important; } .hhs-top-bar.hhs-alt-nav .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .hhs-top-bar.hhs-alt-nav .hhs-header-search a i:hover, .hhs-top-bar.hhs-alt-nav .globe_class:hover { color: rgba(0, 0, 0, 1) !important; } .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1.active:after, .hhs-top-bar.hhs-alt-nav .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1:after, .sticky-menu.hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1.active:after, .sticky-menu.hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1:after { background-color: rgba(0, 164, 189, 1.0); } /* CTA */ .hhs-header-cta .cta-secondary, .hhs-header-cta .cta-tertiary, .hhs-header-cta .cta-primary { padding: 15px 15px !important; font-size: 10px !important; -webkit-box-shadow: none; box-shadow: none; } /******************************* END *******************************/ /******************************* SIDE MENU *******************************/ .hhs-side-menu { width: 320px; } .hhs-side-menu { background-color: rgba(255, 255, 255, 1.0); } .body-wrapper::after { background-color: rgba(0, 0, 0, 0.3); } /* ICON */ .hamburger-icon .line { background: rgba(0, 102, 51, 1.0); } .hhs-top-bar.hhs-alt-nav .hamburger-icon .line, .sticky-menu .hamburger-icon .line { background: rgba(68, 68, 68, 1.0); } .hamburger-icon.active .line { background: rgba(68, 68, 68, 1.0); } .hhs-side-menu__controls .hhs-lang-switch { right: 70px !important; } /* LANG GLOBE & SEARCH */ .hhs-side-menu .hhs-lang-switch .globe_class:before, .hhs-side-menu .fas{ color: rgba(68, 68, 68, 1.0); } .hhs-top-bar .fas { color: #4A4A4A; } .hhs-side-menu__footer a i, .hhs-side-menu__footer a:visited i { color: #333333; } .hhs-side-menu__footer a:hover i, .hhs-side-menu__footer a:focus i { color: #666666; } /** MAIN MENU **/ .hhs-side-menu .hhs-side-menu__mobile li a { font-size: 18px; font-weight: nomral; color: rgba(102, 102, 102, 1.0); } .hhs-side-menu .hhs-side-menu__mobile li a:hover { color: rgba(0, 0, 0, 1.0); } .hhs-sidebar-nav-toggle i { color: rgba(153, 153, 153, 1.0); } /** EXTRAS MENU **/ .hhs-side-menu__extras .hs-menu-item a, .hhs-side-menu__extras .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper a { font-size: 14px; font-weight: nomral; color: rgba(74, 74, 74, 1); } .hhs-side-menu__extras .hs-menu-item a:hover, .hhs-side-menu__extras .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper a:hover { color: rgba(0, 164, 189, 1); } /* FOR LAST BLOCK IN SIDE MENU */ .hhs-side-menu__extras {flex: 1;} @media (max-width: 575px) { .hhs-side-menu { width: 100%; } } /******************************* END *******************************/ /******************************* MEGA MENU *******************************/ /******************************* END *******************************/ /******************************* RESPONSIVE SIDE MENU *******************************/ .hhs-menu-toggle { display: none; } @media (max-width: 960px) { .hhs-menu-toggle { display: block; } } @media (max-width: 920px) { .hhs-menu-toggle { display: block; } } /* CTAS */ .hhs-side-menu__ctas .hhs-side-cta-1, .hhs-side-menu__ctas .hhs-side-cta-2{ display: none; } @media (max-width: 960px) { .hhs-extras-ctas, .hhs-extras-ctas .hhs-head-cta-1 { display: none; } .hhs-side-menu__ctas .hhs-side-cta-1 { display: inline-block; } } @media (max-width: 920px) { .hhs-extras-ctas .hhs-head-cta-2 { display: none; } .hhs-side-menu__ctas .hhs-side-cta-2 { display: inline-block; } } /* MAIN NAV */ @media (min-width: 768px) { .hhs-side-menu__mobile { display: none; } } @media (max-width: 768px) { .main-nav .sc-site-header__menu { display: none; } } /* FORM */ /******************************* END *******************************/ /******************************* HEADER HAT *******************************/ .hhs-header-hat { background-color: rgba(0, 102, 51, 1.0); padding: 5px 0; } .hhs-hat-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1 a { color: rgba(255, 255, 255, 1.0); font-size: 12px; font-weight: normal; } .hhs-hat-menu .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-menu-depth-1 a:hover { color: rgba(238, 238, 238, 1.0); } @media (max-width: 575px) { .hhs-header-hat { display: none; } } /******************************* END *******************************/ /** TABLET CSS **/ @media (max-width: 768px) { .custom-menu-primary .hs-menu-wrapper > ul { margin-top: 10px !important; } .custom-menu-primary .hs-menu-wrapper > ul, .custom-menu-primary .hs-menu-wrapper > ul li.active a:hover{ background-color: rgba(0, 102, 51, 1) !important; } .hhs-top-bar .hs-menu-wrapper.hs-menu-flow-horizontal>ul li a:hover, .custom-menu-primary .hs-menu-wrapper > ul li.active a:hover { color: #FFFFFF ; } .custom-menu-primary .hs-menu-wrapper > ul li{ border-top: 1px solid rgba(255, 255, 255, .2) !important; } .custom-menu-primary .hs-menu-wrapper > ul ul li{ background-color: rgba(255, 255, 255, .15); } .sticky-menu.active { position: static !important; } .sticky-menu.active { display: none !important; height: 0px !important; } } /** MOBILE CSS **/ @media (max-width: 575px) { .logo-standard, .logo-sticky { max-width: 140px !important; } .hhs-nav-opt-items .hhs-header-search { right: 3px; } .hhs-nav-opt-items .hhs-lang-switch { right: 33px; } } </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63706222910/1726675698575/VERISTAT-CLEAN-2022/css/modules/global-footer.min.css"> <style> /******************************* MAIN DESKTOP NAV STYLE *******************************/ #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 50px; padding-bottom: 25px; background-color: rgba(244, 244, 244, 1.0); } /** NAVIGATION COLUMNS STYLE **/ .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a { color: #888888 !important; } .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a:hover, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal>ul li.hs-item-has-children ul.hs-menu-children-wrapper li a:hover, .hhs-foot-nav-col .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a:hover { color: #555555 !important; } .foot-nav-title, .hhs-foot-rss h5, .hhs-foot-nav-col h5 { margin-bottom: 28px; color: #006633; } .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text p, .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text l1, .hhs-foot-rss .hs_cos_wrapper_type_inline_rich_text span, .hhs-foot-rss label{ color: #4A4A4A; } .hhs-foot-base-nav .hs-menu-wrapper.hs-menu-flow-horizontal > ul li a { font-size: 13px; } /** BLOG POST STYLE **/ .hhs-footer-mod .hhs-post-content a h6 { color: #FFFFFF; font-size: 16px; line-height: 20px; } .hhs-footer-mod .hhs-post-summary p { color: #4A4A4A; font-size: 14px; line-height: 18px; } .hhs-foot-rss .hs-rss-title:hover { color: #00a4bd; } .hhs-footer-mod .hhs-post-feat-img { min-height: 120px; } .hhs-foot-rss .hs-rss-item.hs-with-featured-image .hs-rss-item-text { margin-top: 120px; } .hhs-foot-break-line { border-color: #006633; } .hhs-foot-copyright { color: #006633; } /** TOGGLE COLLAPSE **/ @media (max-width: 575px) { .hhs-foot-nav-col .hhs-col-content { display: none; text-align: center; } .hhs-foot-nav-col .hhs-col-content.open-menu { display: block; text-align: center; } } /** SOCIAL ICONS **/#hs_cos_wrapper_global_footer .hhs-social-con i { color: #006633;} #hs_cos_wrapper_global_footer .hhs-social-con i:hover {color: #9CCD4E;}/** TABLET CSS **/ @media (max-width: 768px) { #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 25px; padding-bottom: 25px; } } /** BACK TO TOP **/ #return-to-top { background: rgba(68, 68, 68, 0.7); } #return-to-top:hover { background: rgba(68, 68, 68, 0.9); } /** MOBILE CSS **/ @media (max-width: 575px) { #hs_cos_wrapper_global_footer .hhs-footer-mod { padding-top: 25px; padding-bottom: 25px; } .hhs-foot-nav-col { border-color: #006633; } } </style> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/module_assets/180374737055/1731997198826/module_180374737055_VERIS_-_Row_-_Breadcrumb_-_GG.min.css"> <link rel="stylesheet" href="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63705315696/1726675693152/VERISTAT-CLEAN-2022/css/modules/row-blog-post-thumbnails.min.css"> <style> /******************************* ROW STYLE *******************************/ #hs_cos_wrapper_module_16963753463768 .hhs-blog-post-mod { padding-top: 50px; padding-bottom: 50px;background-color: rgba(255, 255, 255,1);} @media (max-width: 768px) { #hs_cos_wrapper_module_16963753463768 .hhs-blog-post-mod { padding-top: 50px; padding-bottom: 50px; } } @media (max-width: 575px) { #hs_cos_wrapper_module_16963753463768 .hhs-blog-post-mod { padding-top: 25px; padding-bottom: 25px; } }#hs_cos_wrapper_module_16963753463768 h6.reading-minutes { font-size: 12px; }/* PARALLAX */ /* HERO OVERLAY *//* PULL UP ROW *//* VIDEO BACKGROUND *//* WAVE *//******************************* FEATURED IMAGES *******************************/ .hhs-post-feat-img.lazy-background { background-image: url("https://507386.fs1.hubspotusercontent-na1.net/hubfs/507386/CLEAN-images/lazy-imgs/lazy-img-800x500.png"); } #hs_cos_wrapper_module_16963753463768 #hhs-post-thumb_module_16963753463768-1 .hhs-post-feat-img.lazy-background.visible { background-image: url(https://www.veristat.com/hubfs/Advanced%20Therapies%2025/Advanced%20Therapies%202025.png); } .hhs-post-feat-img.lazy-background { background-image: url("https://507386.fs1.hubspotusercontent-na1.net/hubfs/507386/CLEAN-images/lazy-imgs/lazy-img-800x500.png"); } #hs_cos_wrapper_module_16963753463768 #hhs-post-thumb_module_16963753463768-2 .hhs-post-feat-img.lazy-background.visible { background-image: url(https://www.veristat.com/hubfs/DIA%20EU%2025/DIA%20Europe%202025.png); } #hs_cos_wrapper_module_16963753463768 .hhs-post-feat-img { min-height: 200px; } /******************************* END*******************************/ /******************************* CARD STYLE *******************************/ #hs_cos_wrapper_module_16963753463768 .hhs-blog-post-card { background-color: rgba(255, 255, 255,1); padding: 32px;-webkit-box-shadow: 0 0 15px 0 rgba(0,0,0,0.1); box-shadow: 0 0 15px 0 rgba(0,0,0,0.1);} #hs_cos_wrapper_module_16963753463768 .hhs-post-content { padding: 25px; } /* TEXT STYLES */ #hs_cos_wrapper_module_16963753463768 .hhs-post-summary, #hs_cos_wrapper_module_16963753463768 .hhs-post-summary p, #hs_cos_wrapper_module_16963753463768 .hhs-post-summary li { font-size: 16px; }</style> <style> @font-face { font-family: "Lato"; font-weight: 300; font-style: normal; font-display: swap; src: url("/_hcms/googlefonts/Lato/300.woff2") format("woff2"), url("/_hcms/googlefonts/Lato/300.woff") format("woff"); } @font-face { font-family: "Lato"; font-weight: 400; font-style: normal; font-display: swap; src: url("/_hcms/googlefonts/Lato/regular.woff2") format("woff2"), url("/_hcms/googlefonts/Lato/regular.woff") format("woff"); } @font-face { font-family: "Lato"; font-weight: 700; font-style: normal; font-display: swap; src: url("/_hcms/googlefonts/Lato/700.woff2") format("woff2"), url("/_hcms/googlefonts/Lato/700.woff") format("woff"); } </style>  <script> var _hsp = window._hsp = window._hsp || []; window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} var useGoogleConsentModeV2 = true; var waitForUpdateMillis = 1000; if (!window._hsGoogleConsentRunOnce) { window._hsGoogleConsentRunOnce = true; gtag('consent', 'default', { 'ad_storage': 'denied', 'analytics_storage': 'denied', 'ad_user_data': 'denied', 'ad_personalization': 'denied', 'wait_for_update': waitForUpdateMillis }); if (useGoogleConsentModeV2) { _hsp.push(['useGoogleConsentModeV2']) } else { _hsp.push(['addPrivacyConsentListener', function(consent){ var hasAnalyticsConsent = consent && (consent.allowed || (consent.categories && consent.categories.analytics)); var hasAdsConsent = consent && (consent.allowed || (consent.categories && consent.categories.advertisement)); gtag('consent', 'update', { 'ad_storage': hasAdsConsent ? 'granted' : 'denied', 'analytics_storage': hasAnalyticsConsent ? 'granted' : 'denied', 'ad_user_data': hasAdsConsent ? 'granted' : 'denied', 'ad_personalization': hasAdsConsent ? 'granted' : 'denied' }); }]); } } gtag('js', new Date()); gtag('set', 'developer_id.dZTQ1Zm', true); gtag('config', 'G-348266650'); </script> <script async src="https://www.googletagmanager.com/gtag/js?id=G-348266650"></script>   <script type="text/javascript"> adroll_adv_id = "VSHM542N5FF5FJP6IEO2QH"; adroll_pix_id = "MBMFZDFJSFEXXPPLWQRI74"; adroll_version = "2.0"; (function(w, d, e, o, a) { w.__adroll_loaded = true; w.adroll = w.adroll || []; w.adroll.f = [ 'setProperties', 'identify', 'track' ]; var roundtripUrl = "https://s.adroll.com/j/" + adroll_adv_id + "/roundtrip.js"; for (a = 0; a < w.adroll.f.length; a++) { w.adroll[w.adroll.f[a]] = w.adroll[w.adroll.f[a]] || (function(n) { return function() { w.adroll.push([ n, arguments ]) } })(w.adroll.f[a]) } e = d.createElement('script'); o = d.getElementsByTagName('script')[0]; e.async = 1; e.src = roundtripUrl; o.parentNode.insertBefore(e, o); })(window, document); adroll.track("pageView"); </script>   <script>(function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0], j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src= 'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f); })(window,document,'script','dataLayer','GTM-566BNKD');</script>   <script> var _hsp = window._hsp = window._hsp || []; _hsp.push(['addPrivacyConsentListener', function(consent) { if (consent.allowed || (consent.categories && consent.categories.analytics)) { (function(i,s,o,g,r,a,m){i['GoogleAnalyticsObject']=r;i[r]=i[r]||function(){ (i[r].q=i[r].q||[]).push(arguments)},i[r].l=1*new Date();a=s.createElement(o), m=s.getElementsByTagName(o)[0];a.async=1;a.src=g;m.parentNode.insertBefore(a,m) })(window,document,'script','//www.google-analytics.com/analytics.js','ga'); ga('create','UA-117085249-1','auto'); ga('send','pageview'); }}]); </script>  <meta name="google-site-verification" content="WhJ-2H9i2g9Up4yUREiapnOAyAKJp-QNJd6AjpqzSaE"> <meta name="google-site-verification" content="aXNUNMVnMadLV3B7jowsgE5XdkM7RDbgQ4N1s9aGicU"> <meta name="msvalidate.01" content="F86BB138B7569F11985BCC6C9BE86A2F"> <script src="https://kit.fontawesome.com/6d3932528e.js" crossorigin="anonymous"></script> <link href="https://fonts.googleapis.com/css?family=Lato:300,400,700,900" rel="stylesheet">  <script> (function(h,o,t,j,a,r){ h.hj=h.hj||function(){(h.hj.q=h.hj.q||[]).push(arguments)}; h._hjSettings={hjid:2329027,hjsv:6}; a=o.getElementsByTagName('head')[0]; r=o.createElement('script');r.async=1; r.src=t+h._hjSettings.hjid+j+h._hjSettings.hjsv; a.appendChild(r); })(window,document,'https://static.hotjar.com/c/hotjar-','.js?sv='); </script>  <link rel="preconnect" href="https://dev.visualwebsiteoptimizer.com"> <script type="text/javascript" id="vwoCode"> window._vwo_code || (function() { var account_id=923851, version=2.1, settings_tolerance=2000, hide_element='body', hide_element_style = 'opacity:0 !important;filter:alpha(opacity=0) !important;background:none !important;transition:none !important;', /* DO NOT EDIT BELOW THIS LINE */ f=false,w=window,d=document,v=d.querySelector('#vwoCode'),cK='_vwo_'+account_id+'_settings',cc={};try{var c=JSON.parse(localStorage.getItem('_vwo_'+account_id+'_config'));cc=c&&typeof c==='object'?c:{}}catch(e){}var stT=cc.stT==='session'?w.sessionStorage:w.localStorage;code={nonce:v&&v.nonce,use_existing_jquery:function(){return typeof use_existing_jquery!=='undefined'?use_existing_jquery:undefined},library_tolerance:function(){return typeof library_tolerance!=='undefined'?library_tolerance:undefined},settings_tolerance:function(){return cc.sT||settings_tolerance},hide_element_style:function(){return'{'+(cc.hES||hide_element_style)+'}'},hide_element:function(){if(performance.getEntriesByName('first-contentful-paint')[0]){return''}return typeof cc.hE==='string'?cc.hE:hide_element},getVersion:function(){return version},finish:function(e){if(!f){f=true;var t=d.getElementById('_vis_opt_path_hides');if(t)t.parentNode.removeChild(t);if(e)(new Image).src='https://dev.visualwebsiteoptimizer.com/ee.gif?a='+account_id+e}},finished:function(){return f},addScript:function(e){var t=d.createElement('script');t.type='text/javascript';if(e.src){t.src=e.src}else{t.text=e.text}v&&t.setAttribute('nonce',v.nonce);d.getElementsByTagName('head')[0].appendChild(t)},load:function(e,t){var n=this.getSettings(),i=d.createElement('script'),r=this;t=t||{};if(n){i.textContent=n;d.getElementsByTagName('head')[0].appendChild(i);if(!w.VWO||VWO.caE){stT.removeItem(cK);r.load(e)}}else{var o=new XMLHttpRequest;o.open('GET',e,true);o.withCredentials=!t.dSC;o.responseType=t.responseType||'text';o.onload=function(){if(t.onloadCb){return t.onloadCb(o,e)}if(o.status===200||o.status===304){_vwo_code.addScript({text:o.responseText})}else{_vwo_code.finish('&e=loading_failure:'+e)}};o.onerror=function(){if(t.onerrorCb){return t.onerrorCb(e)}_vwo_code.finish('&e=loading_failure:'+e)};o.send()}},getSettings:function(){try{var e=stT.getItem(cK);if(!e){return}e=JSON.parse(e);if(Date.now()>e.e){stT.removeItem(cK);return}return e.s}catch(e){return}},init:function(){if(d.URL.indexOf('__vwo_disable__')>-1)return;var e=this.settings_tolerance();w._vwo_settings_timer=setTimeout(function(){_vwo_code.finish();stT.removeItem(cK)},e);var t;if(this.hide_element()!=='body'){t=d.createElement('style');var n=this.hide_element(),i=n?n+this.hide_element_style():'',r=d.getElementsByTagName('head')[0];t.setAttribute('id','_vis_opt_path_hides');v&&t.setAttribute('nonce',v.nonce);t.setAttribute('type','text/css');if(t.styleSheet)t.styleSheet.cssText=i;else t.appendChild(d.createTextNode(i));r.appendChild(t)}else{t=d.getElementsByTagName('head')[0];var i=d.createElement('div');i.style.cssText='z-index: 2147483647 !important;position: fixed !important;left: 0 !important;top: 0 !important;width: 100% !important;height: 100% !important;background: white !important;display: block !important;';i.setAttribute('id','_vis_opt_path_hides');i.classList.add('_vis_hide_layer');t.parentNode.insertBefore(i,t.nextSibling)}var o=window._vis_opt_url||d.URL,s='https://dev.visualwebsiteoptimizer.com/j.php?a='+account_id+'&u='+encodeURIComponent(o)+'&vn='+version;if(w.location.search.indexOf('_vwo_xhr')!==-1){this.addScript({src:s})}else{this.load(s+'&x=true')}}};w._vwo_code=code;code.init();})(); </script>  <meta property="og:image" content="https://www.veristat.com/hubfs/Webinar-Orphan%20Drug%20Designation_RAPS1022.jpg"> <meta property="og:image:width" content="1024"> <meta property="og:image:height" content="512"> <meta name="twitter:image" content="https://www.veristat.com/hubfs/Webinar-Orphan%20Drug%20Designation_RAPS1022.jpg"> <meta property="og:url" content="https://www.veristat.com/events/webinar-orphan_drug_designation_raps_1022"> <meta name="twitter:card" content="summary_large_image"> <link rel="canonical" href="https://www.veristat.com/events/webinar-orphan_drug_designation_raps_1022"> <meta property="og:type" content="article"> <link rel="alternate" type="application/rss+xml" href="https://www.veristat.com/events/rss.xml"> <meta name="twitter:domain" content="www.veristat.com"> <script src="//platform.linkedin.com/in.js" type="text/javascript"> lang: en_US </script> <meta http-equiv="content-language" content="en-us"> <script src="https://kit.fontawesome.com/6d3932528e.js" crossorigin="anonymous"></script> <meta name="generator" content="HubSpot"></head> <body> <div class="body-wrapper hs-content-id-82784970848 hs-blog-post hs-blog-id-4607812733"> <header class="header"> <div class="header__container"> <div id="hs_cos_wrapper_global_header_v2" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div class="hhs-header-hat"> <div class="container"> <div class="row"> <div class="col-12"> <nav class="hhs-hat-menu" data-collapsed="true"> <span id="hs_cos_wrapper_global_header_v2_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_simple_menu" style="" data-hs-cos-general-type="widget" data-hs-cos-type="simple_menu"><div id="hs_menu_wrapper_global_header_v2_" class="hs-menu-wrapper active-branch flyouts hs-menu-flow-horizontal" role="navigation" data-sitemap-name="" data-menu-id="" aria-label="Navigation Menu"> <ul role="menu"> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/careers" role="menuitem" target="_self">CAREERS</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/events" role="menuitem" target="_self">EVENTS</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/library" role="menuitem" target="_self">LIBRARY</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/news" role="menuitem" target="_self">NEWS</a></li> </ul> </div></span> </nav> </div> </div> </div> </div> <header id="hhs-main-nav" class="hhs-top-bar"> <div class="container hhs-nav-grid"> <a class="hhs-nav-grid__logo" href="https://www.veristat.com" style="display: inline-block;"> <div class="hhs-header-logo"> <div class="logo-standard"> <img src="https://www.veristat.com/hs-fs/hubfs/logo/logo-small.png?width=270&height=61&name=logo-small.png" alt="logo-small" width="270" height="61" srcset="https://www.veristat.com/hs-fs/hubfs/logo/logo-small.png?width=135&height=31&name=logo-small.png 135w, https://www.veristat.com/hs-fs/hubfs/logo/logo-small.png?width=270&height=61&name=logo-small.png 270w, https://www.veristat.com/hs-fs/hubfs/logo/logo-small.png?width=405&height=92&name=logo-small.png 405w, https://www.veristat.com/hs-fs/hubfs/logo/logo-small.png?width=540&height=122&name=logo-small.png 540w, https://www.veristat.com/hs-fs/hubfs/logo/logo-small.png?width=675&height=153&name=logo-small.png 675w, https://www.veristat.com/hs-fs/hubfs/logo/logo-small.png?width=810&height=183&name=logo-small.png 810w" sizes="(max-width: 270px) 100vw, 270px"> </div> <div class="logo-sticky"> <img src="https://www.veristat.com/hs-fs/hubfs/Veristat_logo.png?width=1952&height=442&name=Veristat_logo.png" alt="Veristat_logo" width="1952" height="442" srcset="https://www.veristat.com/hs-fs/hubfs/Veristat_logo.png?width=976&height=221&name=Veristat_logo.png 976w, https://www.veristat.com/hs-fs/hubfs/Veristat_logo.png?width=1952&height=442&name=Veristat_logo.png 1952w, https://www.veristat.com/hs-fs/hubfs/Veristat_logo.png?width=2928&height=663&name=Veristat_logo.png 2928w, https://www.veristat.com/hs-fs/hubfs/Veristat_logo.png?width=3904&height=884&name=Veristat_logo.png 3904w, https://www.veristat.com/hs-fs/hubfs/Veristat_logo.png?width=4880&height=1105&name=Veristat_logo.png 4880w, https://www.veristat.com/hs-fs/hubfs/Veristat_logo.png?width=5856&height=1326&name=Veristat_logo.png 5856w" sizes="(max-width: 1952px) 100vw, 1952px"> </div> </div> </a> <div class="hhs-nav-grid__menu main-nav"> <nav class="sc-site-header__menu sc-site-header__menu--68224041094 hs-menu-wrapper active-branch flyouts hs-menu-flow-horizontal" aria-label=" menu"> <ul class="hhs-nav-links"> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/why-veristat" target=""> Why Veristat </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/company/about" target=""> About Us </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/approach" target=""> Our Approach </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/company/leadership-team" target=""> Our Leadership </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/corporate-responsibility" target=""> Corporate Responsibility </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Case+Study" target=""> Success Stories </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/news" target=""> News </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/global-reach-locations" target=""> Locations </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/careers" target=""> Careers </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/careers/open-positions" target=""> Open Positions </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/veristat-culture-our-core-values" target=""> Core Values </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/careers/explore-benefits" target=""> Explore Benefits </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/careers/life-at-veristat" target=""> Grow Your Career </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/because-we-care" target=""> Because We Care </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/why-veristat" target=""> Why Veristat </a> </li> </ul> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/therapeutic-expertise" target=""> Therapeutic Areas </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/oncology" target=""> Oncology/Hematology </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/neurology" target=""> Neurology/Psychiatry </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/endocrine-metabolic-disease" target=""> Endocrine/Metabolic </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/immunology-and-inflammation" target=""> Inflammation/Immunology </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/therapeutic-expertise/infectious-disease" target=""> Infectious Disease </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/therapeutic-expertise/covid-19" target=""> COVID-19 </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/cardiology" target=""> Cardiovascular Disease </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/other" target=""> More Therapy Areas </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/solutions" target=""> Solutions </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/full-service-cro-biologics" target=""> Biologics </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/cro-cell-gene" target=""> Cell and Gene Therapies </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/therapeutic-expertise/vaccines" target=""> Vaccine Trials </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/therapeutic-expertise/rare-diseases" target=""> Rare Diseases </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/therapeutic-expertise/pediatric-clinical-trials" target=""> Pediatric </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/decentralizedclinicaltrials" target=""> Decentralized Trials </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/clinical-trial-rescue-programs" target=""> Rescue Trials </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/full-service-solutions" target=""> Full Service </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/clinical-trial-planning" target=""> Clinical Trial Planning </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/clinical-trial-conduct" target=""> Clinical Trial Conduct </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/regulatory-submission" target=""> Regulatory Submission </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/solutions/natural-history-studies" target=""> Natural History Trials </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services" target=""> Services </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/strategic-consulting" target=""> Strategic Consulting </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/adaptive-designs" target=""> Adaptive Designs </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/introduction-statistical-power" target=""> Statistical Power </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/regulatory-affairs-overview" target=""> Regulatory Affairs </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design" target=""> Regulatory Consulting </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-approvals" target=""> Marketing Applications </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/chemistry-manufacturing-controls-cmc" target=""> Chemistry, Manufacturing, and Controls (CMC) </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-agency-meeting-support" target=""> Agency Meetings </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-publishing" target=""> Regulatory Publishing </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/regulatory-medical-device-ivd" target=""> Medical Devices/IVDs </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/clinical-operations" target=""> Clinical Operations </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/clinical-operations/project-management" target=""> Project Management </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/clinical-operations/monitoring" target=""> Monitoring & Site Management </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/patient-recruitment-for-clinical-trials" target=""> Patient Recruitment </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/patient-retention-and-site-engagement" target=""> Patient Retention & Site Engagement </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/medical-affairs-overview" target=""> Medical Affairs </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/safety-pharmacovigilance" target=""> Clinical Trial Safety </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/data-monitoring-committees" target=""> Data Monitoring Committees </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/medical-monitoring-for-clinical-trials" target=""> Medical Monitoring </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/services/regulatory-affairs/medical-writing" target=""> Medical Writing </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/biometrics" target=""> Biometrics </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/data-management" target=""> Data Management </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/biostatistics" target=""> Biostatistics </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/data-monitoring-committees" target=""> Data Monitoring Committees </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/statistical-programming" target=""> Statistical Programming </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/standards-implementation" target=""> Standards Implementation </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/pharmacovigilance" target=""> Pharmacovigilance </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/services/strategic-resourcing" target=""> Resourcing/FSP </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="#" target=""> Knowledge Base </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library" target=""> Library </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/blog" target=""> Blog </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Webinar+Presentation%2C+Webinar+Video+Replay" target=""> Webinars </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Podcast" target=""> Podcasts </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Case+Study" target=""> Success Stories </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://info.veristat.com/latest-newsletter" target=""> Newsletter </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 "> <a href="https://www.veristat.com/contact-us" target=""> Contact Us </a> </li> <li class="hs-menu-item hs-menu-depth-1 "> <a href="https://www.veristat.com/rfp" target=""> RFP </a> </li> </ul> </nav> </div> <div class="hhs-nav-grid__extras"> <div class="hhs-menu-toggle "> <button class="hhs-menu-button hamburger-icon js-toggle-main-nav" id="hamburger-icon" aria-label="Toggle Side Menu"> <span class="line line-1"></span> <span class="line line-2"></span> <span class="line line-3"></span> </button> </div> </div> </div> </header> <div class="hhs-side-menu js-side-menu"> <div class="hhs-side-menu__controls"> <div class="hhs-side-menu__mobile-controls"> </div> <div class="hhs-menu-toggle hhs-menu-toggle--always-show"> <button class="hhs-menu-button hamburger-icon js-toggle-main-nav" aria-label="Toggle Side Menu"> <span class="line line-1"></span> <span class="line line-2"></span> <span class="line line-3"></span> </button> </div> </div> <div class="hhs-side-menu__mobile"> <nav class="sc-site-header__menu sc-site-header__menu--68224041094 hs-menu-wrapper active-branch flyouts hs-menu-flow-vertical" aria-label=" menu"> <ul> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/why-veristat" target=""> Why Veristat <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/company/about" target=""> About Us </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/approach" target=""> Our Approach </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/company/leadership-team" target=""> Our Leadership </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/corporate-responsibility" target=""> Corporate Responsibility </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Case+Study" target=""> Success Stories </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/news" target=""> News </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/global-reach-locations" target=""> Locations </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/careers" target=""> Careers <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/careers/open-positions" target=""> Open Positions </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/veristat-culture-our-core-values" target=""> Core Values </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/careers/explore-benefits" target=""> Explore Benefits </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/careers/life-at-veristat" target=""> Grow Your Career </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/because-we-care" target=""> Because We Care </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/why-veristat" target=""> Why Veristat </a> </li> </ul> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/therapeutic-expertise" target=""> Therapeutic Areas <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/oncology" target=""> Oncology/Hematology </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/neurology" target=""> Neurology/Psychiatry </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/endocrine-metabolic-disease" target=""> Endocrine/Metabolic </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/immunology-and-inflammation" target=""> Inflammation/Immunology </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/therapeutic-expertise/infectious-disease" target=""> Infectious Disease <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/therapeutic-expertise/covid-19" target=""> COVID-19 </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/cardiology" target=""> Cardiovascular Disease </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/therapeutic-expertise/other" target=""> More Therapy Areas </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/solutions" target=""> Solutions <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/full-service-cro-biologics" target=""> Biologics <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/cro-cell-gene" target=""> Cell and Gene Therapies </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/therapeutic-expertise/vaccines" target=""> Vaccine Trials </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/therapeutic-expertise/rare-diseases" target=""> Rare Diseases <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/therapeutic-expertise/pediatric-clinical-trials" target=""> Pediatric </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/decentralizedclinicaltrials" target=""> Decentralized Trials </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/clinical-trial-rescue-programs" target=""> Rescue Trials </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/full-service-solutions" target=""> Full Service <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/clinical-trial-planning" target=""> Clinical Trial Planning </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/clinical-trial-conduct" target=""> Clinical Trial Conduct </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/regulatory-submission" target=""> Regulatory Submission </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/solutions/natural-history-studies" target=""> Natural History Trials </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services" target=""> Services <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/strategic-consulting" target=""> Strategic Consulting <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/adaptive-designs" target=""> Adaptive Designs </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/introduction-statistical-power" target=""> Statistical Power </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/regulatory-affairs-overview" target=""> Regulatory Affairs <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design" target=""> Regulatory Consulting </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-approvals" target=""> Marketing Applications </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/chemistry-manufacturing-controls-cmc" target=""> Chemistry, Manufacturing, and Controls (CMC) </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-agency-meeting-support" target=""> Agency Meetings </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/regulatory-affairs/regulatory-publishing" target=""> Regulatory Publishing </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/regulatory-medical-device-ivd" target=""> Medical Devices/IVDs </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/clinical-operations" target=""> Clinical Operations <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/clinical-operations/project-management" target=""> Project Management </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/clinical-operations/monitoring" target=""> Monitoring & Site Management </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/patient-recruitment-for-clinical-trials" target=""> Patient Recruitment </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/patient-retention-and-site-engagement" target=""> Patient Retention & Site Engagement </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/medical-affairs-overview" target=""> Medical Affairs <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/safety-pharmacovigilance" target=""> Clinical Trial Safety </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/data-monitoring-committees" target=""> Data Monitoring Committees </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/medical-monitoring-for-clinical-trials" target=""> Medical Monitoring </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/services/regulatory-affairs/medical-writing" target=""> Medical Writing </a> </li> <li class="hs-menu-item hs-menu-depth-2 hs-item-has-children " aria-haspopup="true"> <a href="https://www.veristat.com/services/biometrics" target=""> Biometrics <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/data-management" target=""> Data Management </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/biostatistics" target=""> Biostatistics </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/medical-affairs/data-monitoring-committees" target=""> Data Monitoring Committees </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/statistical-programming" target=""> Statistical Programming </a> </li> <li class="hs-menu-item hs-menu-depth-3 "> <a href="https://www.veristat.com/services/biometrics/standards-implementation" target=""> Standards Implementation </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/pharmacovigilance" target=""> Pharmacovigilance </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/services/strategic-resourcing" target=""> Resourcing/FSP </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 hs-item-has-children " aria-haspopup="true"> <a href="#" target=""> Knowledge Base <button class="hhs-sidebar-nav-toggle js-sidebar-nav-toggle" aria-label="Toggle Menu"> <i class="fa fa-plus"><span style="display: none;">Toggle Menu</span></i> </button> </a> <ul class="hs-menu-children-wrapper"> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library" target=""> Library </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/blog" target=""> Blog </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Webinar+Presentation%2C+Webinar+Video+Replay" target=""> Webinars </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Podcast" target=""> Podcasts </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://www.veristat.com/library?page_num=1&asset_type=Case+Study" target=""> Success Stories </a> </li> <li class="hs-menu-item hs-menu-depth-2 "> <a href="https://info.veristat.com/latest-newsletter" target=""> Newsletter </a> </li> </ul> </li> <li class="hs-menu-item hs-menu-depth-1 "> <a href="https://www.veristat.com/contact-us" target=""> Contact Us </a> </li> <li class="hs-menu-item hs-menu-depth-1 "> <a href="https://www.veristat.com/rfp" target=""> RFP </a> </li> </ul> </nav> </div> <div class="hhs-side-menu__footer"> </div> </div> </div> </div> </header> <main id="main-content"> <div class="post-page-full"> <div class="blog-header-full"> <div class="blog-header post-header container"> <div id="hs_cos_wrapper_module_180374737055" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module">   <div class="gg-breadcrumb"> <div class="container"> <div class="row"> <div data-wow-delay="none" class="wow none col-sm-12 c1"> <a href="/"> Home </a> >  <a href="/events">Events</a> >   Webinar orphan_drug_designation_raps_1022 </div> </div> </div> </div></div> <div class="blog-header__inner row"> <div class="col-12"> <p class="reading-minutes"> 2 min read </p> <h1 class="blog-post__title"><span id="hs_cos_wrapper_name" class="hs_cos_wrapper hs_cos_wrapper_meta_field hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="meta_field" data-hs-cos-type="text">Webinar | Orphan Drug Designation</span></h1> <div class="blog-post__meta"> </div> </div> </div> </div> </div> <div class="container"> <div class="blog-post row"> <div class="blog-post__body col-lg-8 col-sm-12"> <span id="hs_cos_wrapper_post_body" class="hs_cos_wrapper hs_cos_wrapper_meta_field hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="meta_field" data-hs-cos-type="rich_text"><h4 style="font-weight: bold; line-height: 1.75;"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US"><span>Orphan Drug Designation - The </span><span>Considerations</span><span>, The </span><span>Rewards</span><span>, and How They Differ Between </span><span>The</span><span> </span><span>US and Europe</span></span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></h4> <p> </p> <p style="font-size: 24px;"><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"><span style="font-size: 20px; color: #006633; font-weight: bold;">Recording available now!</span></span></p> <p style="font-size: 20px;"> </p>  <p><span style="color: black;"><img src="https://www.veristat.com/hs-fs/hubfs/blog_images/Blog%20Images%202018/shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg?width=250&name=shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg" alt="shutterstock_360398336_Woman Working From Home_Blog_opt1200" width="250" loading="lazy" style="width: 250px; float: right; margin: 0px 0px 0px 10px;" srcset="https://www.veristat.com/hs-fs/hubfs/blog_images/Blog%20Images%202018/shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg?width=125&name=shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg 125w, https://www.veristat.com/hs-fs/hubfs/blog_images/Blog%20Images%202018/shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg?width=250&name=shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg 250w, https://www.veristat.com/hs-fs/hubfs/blog_images/Blog%20Images%202018/shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg?width=375&name=shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg 375w, https://www.veristat.com/hs-fs/hubfs/blog_images/Blog%20Images%202018/shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg?width=500&name=shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg 500w, https://www.veristat.com/hs-fs/hubfs/blog_images/Blog%20Images%202018/shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg?width=625&name=shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg 625w, https://www.veristat.com/hs-fs/hubfs/blog_images/Blog%20Images%202018/shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg?width=750&name=shutterstock_360398336_Woman%20Working%20From%20Home_Blog_opt1200.jpg 750w" sizes="(max-width: 250px) 100vw, 250px"></span><span style="color: #4a4a4a;"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US"><span>Sponsors developing drugs/biologics intended to prevent, </span><span>diagnose,</span><span> or treat a rare disease or condition should consider applying for Orphan Drug Designation with the FDA, </span><span>EMA</span><span> and other local health authorities.  However, due to varying </span><span>regional and </span><span>local regulations, </span><span>ODD applications should be considered </span><span>from</span><span> different </span><span>angles</span><span>.     </span></span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></span></p> <p> </p> <hr> <p> </p> <p style="font-weight: bold;"><span style="color: #006633;">In this webinar, Regulatory experts working with FDA, EMA, MHRA and Swissmedic will:</span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Share their experiences navigating the requirements, benefits, and nuances of ODD applications</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{"335552541":1,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" aria-setsize="-1" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Discuss specific examples of ODD applications in various regions</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span><br><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"></span></li> </ul> <p><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"><span class="hs-cta-wrapper" id="hs-cta-wrapper-9c797f9e-d59b-4f1e-a5f4-a35aba1589d6"><span class="hs-cta-node hs-cta-9c797f9e-d59b-4f1e-a5f4-a35aba1589d6" id="hs-cta-9c797f9e-d59b-4f1e-a5f4-a35aba1589d6"><a href="https://cta-redirect.hubspot.com/cta/redirect/1333476/9c797f9e-d59b-4f1e-a5f4-a35aba1589d6" target="_blank" rel="noopener"><img class="hs-cta-img" id="hs-cta-img-9c797f9e-d59b-4f1e-a5f4-a35aba1589d6" style="border-width:0px;" src="https://no-cache.hubspot.com/cta/default/1333476/9c797f9e-d59b-4f1e-a5f4-a35aba1589d6.png" alt="VIEW WEBINAR"></a></span><script charset="utf-8" src="/hs/cta/cta/current.js"></script><script type="text/javascript"> hbspt.cta._relativeUrls=true;hbspt.cta.load(1333476, '9c797f9e-d59b-4f1e-a5f4-a35aba1589d6', {"useNewLoader":"true","region":"na1"}); </script></span></span></p> <h3> </h3> <h3> </h3> <h3>Meet the Speakers</h3> <p><span style="color: #006633;"><br><strong><span style="background-color: white;"><img src="https://www.veristat.com/hs-fs/hubfs/mholinger%20headshot.jpg?width=141&name=mholinger%20headshot.jpg" alt="mholinger headshot" width="141" loading="lazy" style="width: 141px; float: left; margin: 0px 20px 0px 0px;" srcset="https://www.veristat.com/hs-fs/hubfs/mholinger%20headshot.jpg?width=71&name=mholinger%20headshot.jpg 71w, https://www.veristat.com/hs-fs/hubfs/mholinger%20headshot.jpg?width=141&name=mholinger%20headshot.jpg 141w, https://www.veristat.com/hs-fs/hubfs/mholinger%20headshot.jpg?width=212&name=mholinger%20headshot.jpg 212w, https://www.veristat.com/hs-fs/hubfs/mholinger%20headshot.jpg?width=282&name=mholinger%20headshot.jpg 282w, https://www.veristat.com/hs-fs/hubfs/mholinger%20headshot.jpg?width=353&name=mholinger%20headshot.jpg 353w, https://www.veristat.com/hs-fs/hubfs/mholinger%20headshot.jpg?width=423&name=mholinger%20headshot.jpg 423w" sizes="(max-width: 141px) 100vw, 141px"></span></strong></span></p> <p><span style="color: #006633;"><strong>Mara Holinger, PhD, RAC<br>Vice President, Regulatory Affairs, Veristat<br></strong></span></p> <p> </p> <p>Mara earned her PhD in Molecular Microbiology from Tufts University School of Medicine and began her career as a lead scientist in anti-cancer research. She now provides pharmaceutical and biotech firms with strategic consulting to prepare their regulatory pathway; to assist in the design of clinical programs; and to assess program gaps and design regulatory road maps.</p> <p><br>Additionally, she is an expert in regulatory agency meeting preparation, moderation and logistical support, and serves as an Authorized Regulatory Representative and US Agent. Mara has written, reviewed, or provided oversight for more than 20 Investigational New Drug Applications (INDs), multiple Orphan Drug Designation (ODD) applications, breakthrough designation applications, special protocol assessments, fast track applications and several New Drug Applications.</p> <p> </p> <p style="line-height: 1.15;">Areas of expertise:</p> <ul style="line-height: 1.15;"> <li style="line-height: 1.15;">FDAs expedited programs including Fast Track Designation, Breakthrough Therapy Designation</li> <li style="line-height: 1.15;">Priority Review Designation and Accelerated Approval</li> <li style="line-height: 1.15;">New Drug Applications (NDAs)</li> <li style="line-height: 1.15;">Investigational New Drug Applications (INDs)</li> <li style="line-height: 1.15;">Orphan Drug Designation (ODD)</li> <li style="line-height: 1.15;">Regulatory pathway strategy</li> <li style="line-height: 1.15;">Clinical program and trial design</li> <li style="line-height: 1.15;">Regulatory gap analysis</li> <li style="line-height: 1.15;">Regulatory agency meeting preparation, moderation and support</li> <li style="line-height: 1.15;">Oncology, endocrinology, idiopathic pulmonary fibrosis, systemic sclerosis, surgical site infections, wound healing</li> <li style="line-height: 1.15;">Gene therapies, 505(b)(2), biosimilars</li> </ul> <p> </p> <p><strong><span style="color: #00734a;"><img src="https://www.veristat.com/hs-fs/hubfs/Julien-Gaudias.jpg?width=170&name=Julien-Gaudias.jpg" alt="Julien-Gaudias" width="170" loading="lazy" style="width: 170px; float: left; margin: 0px 20px 0px 0px;" srcset="https://www.veristat.com/hs-fs/hubfs/Julien-Gaudias.jpg?width=85&name=Julien-Gaudias.jpg 85w, https://www.veristat.com/hs-fs/hubfs/Julien-Gaudias.jpg?width=170&name=Julien-Gaudias.jpg 170w, https://www.veristat.com/hs-fs/hubfs/Julien-Gaudias.jpg?width=255&name=Julien-Gaudias.jpg 255w, https://www.veristat.com/hs-fs/hubfs/Julien-Gaudias.jpg?width=340&name=Julien-Gaudias.jpg 340w, https://www.veristat.com/hs-fs/hubfs/Julien-Gaudias.jpg?width=425&name=Julien-Gaudias.jpg 425w, https://www.veristat.com/hs-fs/hubfs/Julien-Gaudias.jpg?width=510&name=Julien-Gaudias.jpg 510w" sizes="(max-width: 170px) 100vw, 170px">Julien Gaudias</span></strong></p> <p><strong><span style="color: #00734a;">Senior Director Regulatory Affairs, SFL, a Veristat Company<br></span></strong></p> <p> </p> <p><span>Julien is team leader and leads projects from early development to MAA filing and launch of healthcare products. He advices on regulatory strategy, oversees preparation and submission of MAA and interacts with Authorities globally for clients’ products.</span></p> <p><span><br>Julien has extensive experience in pre-submission activities such as CTA, ODD, PIP, scientific advice meetings for medicinal product across broad range of therapeutic areas. He also provides strategic and operational support for the development and life-cycle management of medical devices, IVDs and combination products, including product classification, preparation of Clinical Evaluation Reports and Technical Documentation, and interactions with Notified Bodies.<br>He also advices on regulatory intelligence projects, preparing high quality documents and customized newsletters for clients.</span></p> <p><span><br>Julien holds a PhD in Neurobiology from the Center of Molecular Life Sciences of the University of Basel, Switzerland, and obtained an MSc in Neuroscience from the University of Strasbourg, France.<br></span></p> <p> </p> <p><strong><span style="color: #00734a;"><img src="https://www.veristat.com/hs-fs/hubfs/David-Berner.jpg?width=150&name=David-Berner.jpg" alt="David-Berner" width="150" loading="lazy" style="width: 150px; float: left; margin: 0px 20px 0px 0px;" srcset="https://www.veristat.com/hs-fs/hubfs/David-Berner.jpg?width=75&name=David-Berner.jpg 75w, https://www.veristat.com/hs-fs/hubfs/David-Berner.jpg?width=150&name=David-Berner.jpg 150w, https://www.veristat.com/hs-fs/hubfs/David-Berner.jpg?width=225&name=David-Berner.jpg 225w, https://www.veristat.com/hs-fs/hubfs/David-Berner.jpg?width=300&name=David-Berner.jpg 300w, https://www.veristat.com/hs-fs/hubfs/David-Berner.jpg?width=375&name=David-Berner.jpg 375w, https://www.veristat.com/hs-fs/hubfs/David-Berner.jpg?width=450&name=David-Berner.jpg 450w" sizes="(max-width: 150px) 100vw, 150px">David Berner</span></strong></p> <p><strong><span style="color: #00734a;">Associate Director Regulatory Affairs, SFL, a Veristat Company<br><br></span></strong></p> <p><span>David leads regulatory projects including defining strategy, preparation and review of regulatory documentation to support SFL clients in the development, MAA filing and maintenance of healthcare products. He leads regulatory submissions to Swissmedic and other international Authorities.</span></p> <p><span><br>David holds a PhD in Neurobiology from the University of Basel, Switzerland, and an MSc in Molecular Biology from the Friedrich Miescher Institute/University of Basel.<br></span></p> <p> </p> <p><strong><span style="color: #00734a;"><img src="https://www.veristat.com/hs-fs/hubfs/Ellen%20Truitt%20headshot.jpg?width=127&name=Ellen%20Truitt%20headshot.jpg" alt="Ellen Truitt headshot" width="127" loading="lazy" style="width: 127px; float: left; margin: 0px 20px 0px 0px;" srcset="https://www.veristat.com/hs-fs/hubfs/Ellen%20Truitt%20headshot.jpg?width=64&name=Ellen%20Truitt%20headshot.jpg 64w, https://www.veristat.com/hs-fs/hubfs/Ellen%20Truitt%20headshot.jpg?width=127&name=Ellen%20Truitt%20headshot.jpg 127w, https://www.veristat.com/hs-fs/hubfs/Ellen%20Truitt%20headshot.jpg?width=191&name=Ellen%20Truitt%20headshot.jpg 191w, https://www.veristat.com/hs-fs/hubfs/Ellen%20Truitt%20headshot.jpg?width=254&name=Ellen%20Truitt%20headshot.jpg 254w, https://www.veristat.com/hs-fs/hubfs/Ellen%20Truitt%20headshot.jpg?width=318&name=Ellen%20Truitt%20headshot.jpg 318w, https://www.veristat.com/hs-fs/hubfs/Ellen%20Truitt%20headshot.jpg?width=381&name=Ellen%20Truitt%20headshot.jpg 381w" sizes="(max-width: 127px) 100vw, 127px">Ellen Truitt</span></strong></p> <p><strong><span style="color: #00734a;">Regulatory Affairs Strategist, Veristat<br></span></strong></p> <p> </p> <p><span>Ellen is a Regulatory Affairs Strategist who supports biopharmaceutical firms looking to advance new drugs intended to treat rare diseases across multiple areas of medicine, as well as numerous products in the oncology space. She began her career in biotech and pharma at CBR International Corp. in Boulder, Colorado. Ellen came to Veristat in August of 2019 as a Regulatory Specialist and has since moved to the role of Associate Regulatory Strategist. <br><br>Ellen holds a degree in Chemical & Biological Engineering from Colorado State University. In December 2020, Ellen received the RAC – Drugs certification from RAPS</span><span style="background-color: transparent;">.</span></p> <p> </p> <hr> <h4>Learn More</h4> <ul> <li>View our <a href="/library/fda-expedited-pathways-explained" rel="noopener" target="_blank">Expedited Pathways Infographic</a></li> <li>Learn more about our <a href="/services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design" rel="noopener">Regulatory Consulting Expertise</a></li> <li>Download our  <a href="https://f.hubspotusercontent20.net/hubfs/1333476/library_all-marketing-assets/Veristat_Purpose_of_IND_Infographic.pdf" rel="noopener" target="_blank">IND Infographic</a></li> </ul> <p> </p></span> <div class="col-lg-12 col-sm-8"> </div> <div class="social-sharing-wrapper"> </div> </div> <div class="col-lg-4 col-sm-12"> <div id="hs_cos_wrapper_module_1695959217193187" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <style> .event-index__post-tag, .hhs-tag-list li a, .event-post__tag-link { font-size: .8rem; padding: 5px 10px; color: rgba(250, 250, 250, 1.0); background-color: rgba(0, 145, 174, 0.6); border-radius: 25px 25px 25px 25px; -moz-transition: all 500ms ease-in-out; -ms-transition: all 500ms ease-in-out; -o-transition: all 500ms ease-in-out; transition: all 500ms ease-in-out; margin: 0 5px 5px 0; display: inline-block; line-height: normal; } </style> <div class="sidebar-con"> <div id="hs_cos_wrapper_module_1695959217193187_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_inline_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="inline_rich_text" data-hs-cos-field="richtext_field"></div> </div> <div class="sidebar-con"> <span id="hs_cos_wrapper_module_1695959217193187_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_form" style="" data-hs-cos-general-type="widget" data-hs-cos-type="form"><h3 id="hs_cos_wrapper_form_3450549_title" class="hs_cos_wrapper form-title" data-hs-cos-general-type="widget_field" data-hs-cos-type="text"></h3> <div id="hs_form_target_form_3450549"></div> </span> </div> <footer class="post-footer"> <div class="row-fluid row-separator"> <h4>Share This Event:</h4> <div class="span12"> <a class="social-icon social-facebook" href="https://www.facebook.com/sharer/sharer.php?u=https://www.veristat.com/events/webinar-orphan_drug_designation_raps_1022" target="_blank"> <i class="fa-brands fa-facebook fa-lg" style="color: #006633;"></i></a>   <a class="social-icon social-twitter" href="https://twitter.com/intent/tweet?url=https://www.veristat.com/events/webinar-orphan_drug_designation_raps_1022&text=Webinar%20| Orphan%20Drug%20Designation" target="_blank"> <i class="fa-brands fa-x-twitter fa-lg" style="color: #006633;"></i></a>   <a class="social-icon social-linkedin" href="https://www.linkedin.com/shareArticle?url=https://www.veristat.com/events/webinar-orphan_drug_designation_raps_1022&title=Webinar%20| Orphan%20Drug%20Designation" target="_blank"> <i class="fa-brands fa-linkedin fa-lg" style="color: #006633;"></i></a> </div> </div> <div class="row-fluid row-separator"></div> </footer></div> </div> </div> </div> <div id="hs_cos_wrapper_module_16963753463768" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-blog-post-mod show-mobile show-tablet show-desktop " style=";"><div class="container " style=""> <div class="row"> <div class="col-lg-6 col-md-6 col-sm-12"> <div id="hhs-post-thumb_module_16963753463768-1" class="hhs-blog-post-card"> <a href="https://www.veristat.com/events/advanced-therapies-congress-2025"> <div class="hhs-post-feat-img lazy-background"></div> </a> <div class="hhs-post-content"> <p class="reading-minutes"> 1 min read</p><a href="https://www.veristat.com/events/advanced-therapies-congress-2025"><h4>Advanced Therapies Congress</h4></a> <div class="hhs-post-meta"> <p>Jan 8, 2025  Veristat Events</p> </div> <div class="hhs-post-summary"> <p style="font-weight: bold;">Meet Veristat at the Advanced Therapies Congress 2025</p>  <p><span style="color: #666666;">Veristat is excited to participate in the <span style="font-weight: bold;">Advanced Therapies...</span></span></p> </div> </div> </div> </div> <div class="col-lg-6 col-md-6 col-sm-12"> <div id="hhs-post-thumb_module_16963753463768-2" class="hhs-blog-post-card"> <a href="https://www.veristat.com/events/dia-europe-2025"> <div class="hhs-post-feat-img lazy-background"></div> </a> <div class="hhs-post-content"> <p class="reading-minutes"> 1 min read</p><a href="https://www.veristat.com/events/dia-europe-2025"><h4>DIA Europe</h4></a> <div class="hhs-post-meta"> <p>Jan 8, 2025  Veristat Events</p> </div> <div class="hhs-post-summary"> <p style="font-weight: bold;">Meet Veristat at DIA Europe 2025</p>  <p>Discover what makes Veristat a distinguished name in the life sciences industry....</p> </div> </div> </div> </div> </div> </div> <span class="hhs-row-overlay"></span></div>  </div> </div> </main> <footer class="footer"> <div class="footer__container"> <div id="hs_cos_wrapper_global_footer" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"> <div id="" class="hhs-footer-mod "> <div class="container"><div class="row hhs-foot-nav-cols"><div class="col-lg-3 col-12 col-md-6"> <div class="hhs-foot-nav-col hhs-foot-rss nav-col-1"><h5 class="hide-mobile">Why Veristat?</h5> <button class="foot-nav-title col-head-1 hide-desktop hide-tablet show-mobile">Why Veristat?</button> <div class="hhs-col-content"><span id="hs_cos_wrapper_global_footer_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_simple_menu" style="" data-hs-cos-general-type="widget" data-hs-cos-type="simple_menu"><div id="hs_menu_wrapper_global_footer_" class="hs-menu-wrapper active-branch flyouts hs-menu-flow-horizontal" role="navigation" data-sitemap-name="" data-menu-id="" aria-label="Navigation Menu"> <ul role="menu"> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/company/about" role="menuitem" target="_self">About Us</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/approach" role="menuitem" target="_self">Our Approach</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/company/leadership-team" role="menuitem" target="_self">Our Leadership</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/library?page_num=1&asset_type=Case+Study" role="menuitem" target="_self">Success Stories</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/news" role="menuitem" target="_self">News</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/global-reach-locations-1" role="menuitem" target="_self">Locations</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/careers" role="menuitem" target="_self">Careers</a></li> </ul> </div></span></div> </div> </div> <div class="col-lg-3 col-12 col-md-6"> <div class="hhs-foot-nav-col hhs-foot-rss nav-col-2"><h5 class="hide-mobile">Therapeutic Areas</h5> <button class="foot-nav-title col-head-2 hide-desktop hide-tablet show-mobile">Therapeutic Areas</button> <div class="hhs-col-content"><span id="hs_cos_wrapper_global_footer_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_simple_menu" style="" data-hs-cos-general-type="widget" data-hs-cos-type="simple_menu"><div id="hs_menu_wrapper_global_footer_" class="hs-menu-wrapper active-branch flyouts hs-menu-flow-horizontal" role="navigation" data-sitemap-name="" data-menu-id="" aria-label="Navigation Menu"> <ul role="menu"> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/therapeutic-expertise/oncology" role="menuitem" target="_self">Oncology/Hematology</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/therapeutic-expertise/neurology" role="menuitem" target="_self">Neurology/Psychiatry</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/endocrine-metabolic-disease" role="menuitem" target="_self">Endocrine/Metabolic</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/therapeutic-expertise/immunology-and-inflammation" role="menuitem" target="_self">Inflammation/Immunology</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/therapeutic-expertise/infectious-disease" role="menuitem" target="_self">Infectious Disease</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/therapeutic-expertise/cardiology" role="menuitem" target="_self">Cardiovascular Disease</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/therapeutic-expertise/other" role="menuitem" target="_self">More Therapy Areas</a></li> </ul> </div></span></div> </div> </div><div class="col-lg-3 col-12 col-md-6"> <div class="hhs-foot-nav-col hhs-foot-rss nav-col-3"><h5 class="hide-mobile">Solutions</h5> <button class="foot-nav-title col-head-3 hide-desktop hide-tablet show-mobile">Solutions</button> <div class="hhs-col-content"><span id="hs_cos_wrapper_global_footer_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_simple_menu" style="" data-hs-cos-general-type="widget" data-hs-cos-type="simple_menu"><div id="hs_menu_wrapper_global_footer_" class="hs-menu-wrapper active-branch flyouts hs-menu-flow-horizontal" role="navigation" data-sitemap-name="" data-menu-id="" aria-label="Navigation Menu"> <ul role="menu"> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/full-service-cro-biologics" role="menuitem" target="_self">Biologics</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/therapeutic-expertise/rare-diseases" role="menuitem" target="_self">Rare Diseases</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/decentralizedclinicaltrials" role="menuitem" target="_self">Decentralized Trials</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/clinical-trial-rescue-programs" role="menuitem" target="_self">Rescue Trials </a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/services/full-service-solutions" role="menuitem" target="_self">Full Service</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/solutions/natural-history-studies" role="menuitem" target="_self">Natural History Trials</a></li> </ul> </div></span></div> </div> </div><div class="col-lg-3 col-12 col-md-6"> <div class="hhs-foot-nav-col hhs-foot-rss nav-col-4"><h5 class="hide-mobile">Services</h5> <button class="foot-nav-title col-head-4 hide-desktop hide-tablet show-mobile">Services</button> <div class="hhs-col-content"><span id="hs_cos_wrapper_global_footer_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_simple_menu" style="" data-hs-cos-general-type="widget" data-hs-cos-type="simple_menu"><div id="hs_menu_wrapper_global_footer_" class="hs-menu-wrapper active-branch flyouts hs-menu-flow-horizontal" role="navigation" data-sitemap-name="" data-menu-id="" aria-label="Navigation Menu"> <ul role="menu"> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/services/strategic-consulting" role="menuitem" target="_self">Strategic Consulting </a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/services/regulatory-affairs-overview" role="menuitem" target="_self">Regulatory Affairs</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/services/clinical-operations" role="menuitem" target="_self">Clinical Operations </a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/medical-affairs-overview" role="menuitem" target="_self">Medical Affairs</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/services/regulatory-affairs/medical-writing" role="menuitem" target="_self">Medical Writing</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/services/biometrics" role="menuitem" target="_self">Biometrics</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/pharmacovigilance" role="menuitem" target="_self">Pharmacovigilance</a></li> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/services/strategic-resourcing" role="menuitem" target="_self">Resourcing/FSP</a></li> </ul> </div></span></div> </div> </div></div><div class="w-100 hhs-foot-break-line"></div> <div class="row hhs-foot-nav-base" style="margin-bottom: 25px;"> <div class="col-sm-6 order-2-mobile"><div class="hhs-foot-base-nav"><span id="hs_cos_wrapper_global_footer_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_simple_menu" style="" data-hs-cos-general-type="widget" data-hs-cos-type="simple_menu"><div id="hs_menu_wrapper_global_footer_" class="hs-menu-wrapper active-branch flyouts hs-menu-flow-horizontal" role="navigation" data-sitemap-name="" data-menu-id="" aria-label="Navigation Menu"> <ul role="menu"> <li class="hs-menu-item hs-menu-depth-1" role="none"><a href="https://www.veristat.com/privacy-policy" role="menuitem" target="_self">Privacy Policy</a></li> </ul> </div></span></div> <p class="hhs-foot-copyright">© 2025 Veristat, LLC. All rights reserved. Veristat is a trademark of Veristat, LLC. All other trademarks are the property of their respective owners.</p> </div> <div class="col-sm-6 order-1-mobile"><div class="hhs-social-con"><a href="https://www.facebook.com/VeristatCRO" target="blank"><i class="fab fa-facebook-f" aria-hidden="true"><span>Facebook</span></i></a><a href="https://twitter.com/VeristatCRO" target="blank"><i class="fa-brands fa-x-twitter" aria-hidden="true"><span>Twitter</span></i></a><a href="https://www.linkedin.com/company/veristat-llc/" target="blank"><i class="fab fa-linkedin-in" aria-hidden="true"><span>LinkedIn</span></i></a><a href="https://www.youtube.com/@veristat" target="blank"><i class="fab fa-youtube" aria-hidden="true"><span>YouTube</span></i></a></div></div> </div> </div> </div> <a href="javascript:" id="return-to-top"><i class="fas fa-chevron-up" aria-hidden="true"><span>Return to Top</span></i></a></div> </div> </footer> </div>  <script defer src="/hs/hsstatic/content-cwv-embed/static-1.1293/embed.js"></script> <script> var element = document.getElementById("hhs-main-nav"); element.classList.add("hhs-alt-nav"); </script> <script src="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63706202039/1726675695703/VERISTAT-CLEAN-2022/js/clean-theme.min.js"></script> <script defer src="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63711291227/1726675697567/VERISTAT-CLEAN-2022/js/jquery-modal-min.min.js"></script> <script> var hsVars = hsVars || {}; hsVars['language'] = 'en-us'; </script> <script src="/hs/hsstatic/cos-i18n/static-1.53/bundles/project.js"></script> <script src="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/template_assets/63706222916/1726675695334/VERISTAT-CLEAN-2022/js/mega-menu.min.js"></script> <script> $( document ).ready(function() { var hamburger = $('.js-toggle-main-nav'); hamburger.click(function() { hamburger.toggleClass('active'); $('.js-side-menu').toggleClass('is-open'); $('.body-wrapper').toggleClass('nav-is-open'); return false; }); }); $('.js-sidebar-nav-toggle').on('click', function(e) { e.preventDefault(); $(this).toggleClass('is-open'); $(this).parent().next().toggleClass('is-open'); }); // THIS IS FOR THE STICKY HEADER $(function() { //caches a jQuery object containing the header element var header = $(".hhs-top-bar"); $(window).scroll(function() { var scroll = $(window).scrollTop(); if (scroll >= 400) { header.addClass("sticky-menu"); } else { header.removeClass('sticky-menu'); } }); }); $(window).scroll(function(){ // Variables var $body = $(".sticky-menu"); var windowScrollTop = $(window).scrollTop(); var scroll = $(window).scrollTop(); if (scroll >= 200) { $body.addClass("active"); } else { $body.removeClass('active'); } }); // THIS IS FOR THE STICKY HEADER $(function() { //caches a jQuery object containing the header element var header = $(".hhs-header-mod"); $(window).scroll(function() { var scroll = $(window).scrollTop(); if (scroll >= 400) { header.addClass("sticky-menu"); } else { header.removeClass('sticky-menu'); } }); }); $(window).scroll(function(){ // Variables var $body = $(".sticky-menu"); var windowScrollTop = $(window).scrollTop(); var scroll = $(window).scrollTop(); if (scroll >= 200) { $body.addClass("active"); } else { $body.removeClass('active'); } }); </script> <script src="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/module_assets/63711371061/1695764154788/module_63711371061_Global_Footer.min.js"></script> <script defer> $(function (e) { $('.foot-nav-title.col-head-1').click(function () { $(this).next('.hhs-foot-nav-col.nav-col-1 .hhs-col-content').slideToggle(250); $('.foot-nav-title').toggleClass('is-active'); $('.hhs-foot-nav-col.nav-col-1 .hhs-col-content').toggleClass('open-menu'); return false; }); $('.foot-nav-title.col-head-2').click(function () { $(this).next('.hhs-foot-nav-col.nav-col-2 .hhs-col-content').slideToggle(250); $('.foot-nav-title').toggleClass('is-active'); $('.hhs-foot-nav-col.nav-col-2 .hhs-col-content').toggleClass('open-menu'); return false; }); $('.foot-nav-title.col-head-3').click(function () { $(this).next('.hhs-foot-nav-col.nav-col-3 .hhs-col-content').slideToggle(250); $('.foot-nav-title').toggleClass('is-active'); $('.hhs-foot-nav-col.nav-col-3 .hhs-col-content').toggleClass('open-menu'); return false; }); $('.foot-nav-title.col-head-4').click(function () { $(this).next('.hhs-foot-nav-col.nav-col-4 .hhs-col-content').slideToggle(250); $('.foot-nav-title').toggleClass('is-active'); $('.hhs-foot-nav-col.nav-col-4 .hhs-col-content').toggleClass('open-menu'); return false; }); }); </script> <script defer> var txt = ""; txt += "<p>Browser CodeName: " + navigator.appCodeName + "</p>"; txt += "<p>Browser Name: " + navigator.appName + "</p>"; txt += "<p>Browser Version: " + navigator.appVersion + "</p>"; txt += "<p>Cookies Enabled: " + navigator.cookieEnabled + "</p>"; txt += "<p>Browser Language: " + navigator.language + "</p>"; txt += "<p>Browser Online: " + navigator.onLine + "</p>"; txt += "<p>Platform: " + navigator.platform + "</p>"; txt += "<p>User-agent header: " + navigator.userAgent + "</p>"; </script>  <script data-hs-allowed="true" src="/_hcms/forms/v2.js"></script> <script data-hs-allowed="true"> var options = { portalId: '1333476', formId: '63f2fbdd-19d0-4a05-beb0-842eecc77c37', formInstanceId: '531', pageId: '82784970848', region: 'na1', pageName: "Webinar |\u00A0Orphan Drug Designation", inlineMessage: "Thanks for submitting the form.", rawInlineMessage: "Thanks for submitting the form.", hsFormKey: "52dc67628d3713b6147d5755c998221d", css: '', target: '#hs_form_target_form_3450549', contentType: "blog-post", formsBaseUrl: '/_hcms/forms/', formData: { cssClass: 'hs-form stacked hs-custom-form' } }; options.getExtraMetaDataBeforeSubmit = function() { var metadata = {}; if (hbspt.targetedContentMetadata) { var count = hbspt.targetedContentMetadata.length; var targetedContentData = []; for (var i = 0; i < count; i++) { var tc = hbspt.targetedContentMetadata[i]; if ( tc.length !== 3) { continue; } targetedContentData.push({ definitionId: tc[0], criterionId: tc[1], smartTypeId: tc[2] }); } metadata["targetedContentMetadata"] = JSON.stringify(targetedContentData); } return metadata; }; hbspt.forms.create(options); </script> <script src="https://www.veristat.com/hs-fs/hub/1333476/hub_generated/module_assets/137732889174/1696375340092/module_137732889174_VERIS_-_Blog_-_Recent_Event_Thumbs.min.js"></script>  <script type="text/javascript"> var _hsq = _hsq || []; _hsq.push(["setContentType", "blog-post"]); _hsq.push(["setCanonicalUrl", "https:\/\/www.veristat.com\/events\/webinar-orphan_drug_designation_raps_1022"]); _hsq.push(["setPageId", "82784970848"]); _hsq.push(["setContentMetadata", { "contentPageId": 82784970848, "legacyPageId": "82784970848", "contentFolderId": null, "contentGroupId": 4607812733, "abTestId": null, "languageVariantId": 82784970848, "languageCode": "en-us", }]); </script> <script type="text/javascript" id="hs-script-loader" async defer src="/hs/scriptloader/1333476.js"></script>  <script type="text/javascript"> var hsVars = { render_id: "780d407d-6933-4ad8-93db-12a6b341e235", ticks: 1738931207439, page_id: 82784970848, content_group_id: 4607812733, portal_id: 1333476, app_hs_base_url: "https://app.hubspot.com", cp_hs_base_url: "https://cp.hubspot.com", language: "en-us", analytics_page_type: "blog-post", scp_content_type: "", analytics_page_id: "82784970848", category_id: 3, folder_id: 0, is_hubspot_user: false } </script> <script defer src="/hs/hsstatic/HubspotToolsMenu/static-1.393/js/index.js"></script>  <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-566BNKD" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript>  <script type="text/javascript"> _linkedin_partner_id = "699986"; window._linkedin_data_partner_ids = window._linkedin_data_partner_ids || []; window._linkedin_data_partner_ids.push(_linkedin_partner_id); </script><script type="text/javascript"> (function(l) { if (!l){window.lintrk = function(a,b){window.lintrk.q.push([a,b])}; window.lintrk.q=[]} var s = document.getElementsByTagName("script")[0]; var b = document.createElement("script"); b.type = "text/javascript";b.async = true; b.src = "https://snap.licdn.com/li.lms-analytics/insight.min.js"; s.parentNode.insertBefore(b, s);})(window.lintrk); </script> <noscript> <img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=699986&fmt=gif"> </noscript> <div id="fb-root"></div> <script>(function(d, s, id) { var js, fjs = d.getElementsByTagName(s)[0]; if (d.getElementById(id)) return; js = d.createElement(s); js.id = id; js.src = "//connect.facebook.net/en_US/sdk.js#xfbml=1&version=v3.0"; fjs.parentNode.insertBefore(js, fjs); }(document, 'script', 'facebook-jssdk'));</script> <script>!function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0];if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src="https://platform.twitter.com/widgets.js";fjs.parentNode.insertBefore(js,fjs);}}(document,"script","twitter-wjs");</script> </body></html>

CINXE.COM

Webinar | Orphan Drug Designation