{"id":6870,"date":"2025-09-08T23:27:02","date_gmt":"2025-09-08T21:27:02","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=news-events-news&p=6870"},"modified":"2025-11-26T15:03:03","modified_gmt":"2025-11-26T14:03:03","slug":"combine-european-cross-sector-initiative-to-streamline-combined-studies","status":"publish","type":"news-events-news","link":"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/combine-european-cross-sector-initiative-to-streamline-combined-studies\/","title":{"rendered":"COMBINE: European cross-sector initiative to streamline combined studies"},"content":{"rendered":"\t\t
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\n\t\t\t\t\t\t\t\t\t28\/Jul\/25\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
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COMBINE: European cross-sector initiative to streamline combined studies<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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In June 2025, a pilot coordinated assessment process for multinational studies that combine a medicinal product and an in vitro diagnostic medical device was launched as part of Project 1 of the European COMBINE programme. Learn how to apply…<\/p>

For the first time, sponsors can test a coordinated assessment involving a clinical trial of an investigational medicinal product (IMP) together with a performance study of an in vitro diagnostic (IVD) and at a later stage an investigation of a medical device via the European COMBINE Projects<\/p>

What\u2019s the goal?
\u2705 Reduce administrative burden
\u2705 Speed up patient access to innovative combined treatments
\u2705 Harmonise requirements under CTR, MDR and IVDR<\/p>

Although the pilot phase has just begun, one thing is clear: Combined studies can be a regulatory maze \u2014 but they don\u2019t have to be.
We know the ins and outs of drug trials under the CTR and medical device studies \u2014 so we\u2019re ready to help our clients explore this new pilot project and make the most of it.
Let\u2019s make combined studies less complicated \u2014 and more impactful!
Planning a combined study?\u00a0Let\u2019s talk!<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

In June 2025, a pilot coordinated assessment process for multinational studies that combine a medicinal product and an in vitro diagnostic medical\u2026<\/p>\n","protected":false},"template":"","class_list":["post-6870","news-events-news","type-news-events-news","status-publish","hentry"],"yoast_head":"\nCOMBINE: European cross-sector initiative to streamline combined studies - FGK Group<\/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:\/\/fgk-group.com\/de\/news-konferenzen\/news\/combine-european-cross-sector-initiative-to-streamline-combined-studies\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"COMBINE: European cross-sector initiative to streamline combined studies - FGK Group\" \/>\n<meta property=\"og:description\" content=\"In June 2025, a pilot coordinated assessment process for multinational studies that combine a medicinal product and an in vitro diagnostic medical\u2026\" \/>\n<meta property=\"og:url\" content=\"https:\/\/fgk-group.com\/de\/news-konferenzen\/news\/combine-european-cross-sector-initiative-to-streamline-combined-studies\/\" \/>\n<meta property=\"og:site_name\" content=\"FGK Group\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-26T14:03:03+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/combine-european-cross-sector-initiative-to-streamline-combined-studies\\\/\",\"url\":\"https:\\\/\\\/fgk-group.com\\\/de\\\/news-konferenzen\\\/news\\\/combine-european-cross-sector-initiative-to-streamline-combined-studies\\\/\",\"name\":\"COMBINE: European cross-sector initiative to streamline combined studies - 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