{"id":3458,"date":"2024-08-14T12:55:28","date_gmt":"2024-08-14T10:55:28","guid":{"rendered":"https:\/\/www.hcsth.com\/?page_id=3458"},"modified":"2024-10-21T14:29:49","modified_gmt":"2024-10-21T12:29:49","slug":"news","status":"publish","type":"page","link":"https:\/\/www.hcsth.com\/de\/news\/","title":{"rendered":"News"},"content":{"rendered":"

NEWS & EVENTS<\/h1>\n\t

\n\t\t\t\tLatest News\n\t\t\t<\/h3>\n\t\t\t\t\t\t

\n\t\t\t\tUmfassender Leitfaden f\u00fcr die Umstellung auf CTIS<\/a>\t\t\t<\/h4>\n\t\t\t\t\t\t\t\tUm klinische Pr\u00fcfungen, die zuvor im Rahmen der EU-Richtlinie \u00fcber klinische Pr\u00fcfungen genehmigt wurden, erfolgreich auf das EU-Informationssystem f\u00fcr klinische Pr\u00fcfungen (CTIS) umzustellen, m\u00fcssen die Sponsoren mehrere wesentliche Vorbereitungsma\u00dfnahmen ergreifen. Diese Vorbereitungsschritte k\u00f6nnen umfangreich sein und werden oft missverstanden, was die Notwendigkeit einer gr\u00fcndlichen Vorbereitung unterstreicht. Erste Vorbereitungen Beginnen Sie damit, sicherzustellen, dass Sie \u00fcber eine Erkl\u00e4rung [...]\n\t\t\t\t\tRead More →<\/a>\t\t\n\t\t\t\t\t\t

\n\t\t\t\tAllowing Sufficient Time for Legal Representative Evaluation in Compliance with the Clinical Trials Regulation<\/a>\t\t\t<\/h4>\n\t\t\t\t\t\t\t\tThe implementation of the Clinical Trials Regulation (CTR) has introduced additional complexities for non-EU sponsors, particularly concerning the obligations of the legal representative. Non-EU sponsors are mandated to appoint an EU-based legal representative to ensure compliance with CTR standards. While the requirement for a legal representative is not new, the CTR explicitly tasks them with […]\n\t\t\t\t\tRead More →<\/a>\t\t\n\t\t\t\t\t\t

\n\t\t\t\tUnderstanding SME Status: A Catalyst for Innovation<\/a>\t\t\t<\/h4>\n\t\t\t\t\t\t\t\tThe European Medicines Agency (EMA) offers a pivotal advantage to Small and Medium-Sized Enterprises (SMEs) engaged in the development of medicinal products for both human and veterinary applications. The designation of SME Status serves as a strategic initiative designed to foster innovation and encourage the creation of novel therapies. Instituted through the SME Regulation of […]\n\t\t\t\t\tRead More →<\/a>\t\t\n\t\t\t\t\t\t

\n\t\t\t\tThe Significance of Data Transparency: Posting Trial Results on EudraCT and CTIS<\/a>\t\t\t<\/h4>\n\t\t\t\t\t\t\t\tWithin the context of the Clinical Trial Regulation, there is an essential emphasis on transparency. It is imperative that sponsors recognize their obligations concerning data transparency for trials executed in the EU, specifically those concluding under the Clinical Trial Directive (CTD). Sponsors are obligated to ensure that results from such studies are submitted to the […]\n\t\t\t\t\tRead More →<\/a>\t\t\n\t

\n\t\t\t\tEvents\n\t\t\t<\/h3>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\"\"\n\t\t\t\t<\/a>\n\t\t\t\t\t\t

\n\t\t\t\tCPHI India 2024<\/a>\t\t\t<\/h4>\n

26 Nov 2024 – 28 Nov 2024<\/strong><\/h4>\n
Location: India Expo Centre, Greater Noida, Delhi NCR<\/h6>\n
\n

Jedes reCAPTCHA-Antworttoken eines Nutzers ist zwei Minuten lang g\u00fcltig und kann nur einmal<\/em> \u00fcberpr\u00fcft werden, um Replay-Angriffe zu verhindern. Wenn Sie ein neues Token ben\u00f6tigen, k\u00f6nnen Sie die reCAPTCHA-\u00dcberpr\u00fcfung noch einmal ausf\u00fchren.<\/p>","protected":false},"excerpt":{"rendered":"

NEWS & EVENTS Latest News Comprehensive Guide to Transitioning to CTIS To successfully transition clinical trials to the EU Clinical Trials Information System (CTIS) from those previously approved under the EU Clinical Trials Directive, sponsors must undertake several essential preparatory measures. These preparatory steps can be extensive and often misunderstood, underscoring the necessity for thorough […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-3458","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages\/3458","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/comments?post=3458"}],"version-history":[{"count":13,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages\/3458\/revisions"}],"predecessor-version":[{"id":3549,"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/pages\/3458\/revisions\/3549"}],"wp:attachment":[{"href":"https:\/\/www.hcsth.com\/de\/wp-json\/wp\/v2\/media?parent=3458"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}