{"id":20191,"date":"2021-09-21T18:16:09","date_gmt":"2021-09-21T16:16:09","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=20191"},"modified":"2021-09-21T18:16:09","modified_gmt":"2021-09-21T16:16:09","slug":"nieuwe-fase-voor-wetgeving-klinische-studies","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/nieuwe-fase-voor-wetgeving-klinische-studies\/","title":{"rendered":"Nieuwe fase voor wetgeving klinische studies"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Binnenkort gaat de Europese wetgeving rond klinische studies definitief een nieuwe fase in. Nu het Clinical Trial Information System (CTIS) voldoet aan alle eisen kan per 31 januari 2022 namelijk de European Clinial Trial Regulation (ECTR) van start. Wie goed voorbereid wil zijn op deze nieuwe manier van werken, kan meerdere trainingen volgen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">De ECTR wordt ingevoerd met een overgangsperiode van drie jaar. In het eerste jaar kan een opdrachtgever ervoor kiezen om het ingediende onderzoeksvoorstel te laten beoordelen volgens de huidige wetgeving of volgens de nieuwe ECTR, via het CTIS-portaal. Om te zorgen dat onderzoekers zich goed voor kunnen bereiden op het nieuwe systeem heeft het EMA een <a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/clinical-trials\/clinical-trials-information-system-training-support\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>trainingsprogramma voor CTIS<\/strong><\/a> beschikbaar gemaakt. Om je verder voor te bereiden op het werken met de ECTR biedt de DCRF ook <a href=\"https:\/\/dcrfacademie.nl\/trainingen\/ectr\/?utm_source=newsletterDCRF&amp;utm_medium=DCRF_Sept21&amp;utm_campaign=ECTR\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>een training aan<\/strong><\/a>.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Voor de uitvoering en goedkeuring van internationale multicenter onderzoeken kon via de Vrijwillige Harmonisatie Procedure (VHP) een voorscreening aangevraagd worden ter ondersteuning van de aanvraag per land. Met de invoering van de ECTR stopt de VHP ook. Uiterlijk 15 oktober kunnen nieuwe aanvragen of amendementen worden ingediend. Meer informatie is te vinden in <a href=\"https:\/\/www.hma.eu\/fileadmin\/dateien\/Human_Medicines\/01-About_HMA\/Working_Groups\/CTFG\/2021_07_CTFG_Conclusion_VHP_Deadlines_for_VHP_Submissions.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>dit bericht<\/strong><\/a> van de <a href=\"https:\/\/www.hma.eu\/ctfg.html\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>CTFG<\/strong><\/a>.\u00a0\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.ccmo.nl\/actueel\/nieuws\/2021\/08\/04\/eu-verordening-geneesmiddelenonderzoek-definitief-van-toepassing-op-31-januari-2022-vhp-stopt-op-15-oktober-2021\" target=\"_blank\" rel=\"noreferrer noopener\">Bericht CCMO<\/a>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/clinical-trials\/clinical-trials-information-system-training-support\" target=\"_blank\" rel=\"noreferrer noopener\">Training CTIS<\/a>&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/dcrfacademie.nl\/trainingen\/ectr\/?utm_source=newsletterDCRF&amp;utm_medium=DCRF_Sept21&amp;utm_campaign=ECTR\" target=\"_blank\" rel=\"noreferrer noopener\">Training ECTR<\/a>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Binnenkort gaat de Europese wetgeving rond klinische studies definitief een nieuwe fase in. Nu het Clinical Trial Information System (CTIS) voldoet aan alle eisen kan per 31 januari 2022 namelijk de European Clinial Trial Regulation (ECTR) van start. Wie goed voorbereid wil zijn op deze nieuwe manier van werken, kan meerdere trainingen volgen. De ECTR [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-20191","post","type-post","status-publish","format-standard","hentry","category-gezondheid"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nieuwe fase voor wetgeving klinische studies - hollandbio<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hollandbio.nl\/en\/nieuws\/nieuwe-fase-voor-wetgeving-klinische-studies\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nieuwe fase voor wetgeving klinische studies - hollandbio\" \/>\n<meta property=\"og:description\" content=\"Binnenkort gaat de Europese wetgeving rond klinische studies definitief een nieuwe fase in. 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