Regulatory intelligence | Insights

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Learn more and subscribe now.</p></div> </div> </div> </div> </div> </a> </div> <div class="col-sm"> <a href="/insights/regulatory/eu-regulations" class="block-link" target="_self"> <div class="container-full"> <div class="card card--title-description card--title-description-blue-light text-left"> <div class="card-body" data-mh="card-body"> <i class="icon-ui-arrow-right"></i> <h4 class="card-title">MDR and IVDR: Where are your legacy products in the compliance process?</h4> <div class="card-text small"> <div> <p>The European Parliament has voted to adopt a proposal by the European Commission to extend the MDR transition period.</p> </div> </div> </div> </div> </div> </a> </div> <div class="col-sm"> <a href="/insights/regulatory/eu-ctr" class="block-link" target="_self"> <div class="container-full"> <div class="card card--title-description card--title-description-purple text-left"> <div class="card-body" data-mh="card-body"> <i class="icon-ui-arrow-right"></i> <h4 class="card-title">EU Clinical Trials Regulation</h4> <div class="card-text small"> <div> <p>Sites and sponsors must follow the new regulations to conduct clinical trials across the European Union. Discover insights on the fundamental changes for interventional clinical trial submissions. </p> </div> </div> </div> </div> </div> </a> </div> </div> </div> </div> </div> <div id="149cc2ab-c04e-4ecc-8872-25a54739f2d7"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> </h3> <div><p class="lead">Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks the flexibility, analytical power and efficiency to address today’s development demands. It is essential to develop a <a href="/solutions/consulting/regulatory-affairs-consulting/regulatory-strategy/" target="_self">regulatory strategy plan</a> early in drug development to identify key challenges that may arise, and <a href="/solutions/consulting/regulatory-affairs-consulting/" target="_self">interact collaboratively with regulatory authorities</a>. This will also enable you to ensure that plan aligns with the profile and <a href="/solutions/consulting/commercial-positioning-consulting/" target="_self">commercialisation for drug development.</a></p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="7bf4bd6e-1771-4952-b685-ab50f6bd11cf"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 1x, https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 1x, https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 1x, https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 1x, https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 1x, https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 1x, https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg?crop=yes&w=2048&h=1251&a=0,0&itok=7TdhkQzX 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/0gfkwg6du5/web/SaMD_whitepaper_1110x678.jpg" width="2221" height="1357" alt="SaMD whitepaper" title="SaMD whitepaper" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2>Clinical strategies to optimise software as a medical device (SaMD) for treating mental health</h2> <h3></h3> <div><p>Mental health disorders affect millions, and with increasing diagnoses, the demand for new, accessible treatments is growing. In this whitepaper, we examine how SaMD, particularly through digital therapeutics, is providing new solutions for mental health management.</p></div> <a class="btn btn-primary btn-md" href="/insights/digital-disruption/clinical-strategies-optimise-samd-treating-mental-health" target="_blank" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="c1a7e6da-1c31-4bc4-82f6-35dd65c2dd71"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 1x, https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 1x, https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 1x, https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 1x, https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 1x, https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 1x, https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg?crop=yes&w=1110&h=678&a=0,0&itok=X3vGe8za 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/vgo0e4trfg/web/Featured%20Section_1110x678_EU%20whitepaper.jpg" width="1110" height="678" alt="EU whitepaper" title="EU whitepaper" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Demystifying EU CTR, MDR and IVDR</h3> <div><p>Download now and demystify the EU regulation process for medical devices, in vitro diagnostic devices and combined studies.</p></div> <a class="btn btn-primary btn-md" href="/insights/regulatory-intelligence/demystifying-eu-ctr-mdr-and-ivdr" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="ad39ab17-547c-48e0-8b1a-d7341e261d84"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 1x, https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 1x, https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 1x, https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 1x, https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 1x, https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 1x, https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg?crop=yes&w=1110&h=678&a=0,0&itok=aAypqg3M 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/qsowqjashy/web/FDA_Podcast_Visual-without-podcast-word.jpg" width="1110" height="678" alt="podcast voice recorder" title="podcast voice recorder" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Navigating FDA Medical Device Regulations</h3> <div><p>Episode 1: Warning letters and recalls</p><p>Hear our Medical Device experts explore FDA warning letters, recalls and the benefits of early clinical and regulatory engagement in this informative podcast. Tune in for practical information to avoid compliance pitfalls and stay ahead of the regulatory curve. </p></div> <a class="btn btn-primary btn-md" href="https://webinars.iconplc.com/detail/videos/medical-device/video/6360641172112/navigating-fda-medical-device-regulations:-warning-letters-and-recalls?autoStart=true" target="_blank" title="Listen to the podcast"> Listen to the podcast </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="a90be3ca-5b89-4b5b-a5b6-eae4190d83d5"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 1x, https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 1x, https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 1x, https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 1x, https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 1x, https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 1x, https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg?crop=yes&w=982&h=600&a=938,0&itok=No5l7JFB 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/4jx7oxlq7u/web/whitepaper-innovative-tools-reg-writing.jpg" width="1920" height="600" alt="whitepaper-innovative-tools-reg-writing" title="whitepaper-innovative-tools-reg-writing" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Using innovative tools and lean writing processes to accelerate regulatory document writing</h3> <div><p>In this whitepaper, we explore how these valuable tools, including software, templates and collaborative work processes, can provide practical solutions to common challenges medical writers face.</p></div> <a class="btn btn-primary btn-md" href="/insights/regulatory-intelligence/accelerate-regulatory-document-writing" target="_blank" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="2ac31a3b-b719-4419-95ff-07b1144810f0"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 1x, https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 1x, https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 1x, https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 1x, https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 1x, https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 1x, https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg?crop=yes&w=555&h=339&a=0,0&itok=pqIPOKCg 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/fefnhadkkw/web/Briefing-Document_Externally-Controlled-Trials.jpg" width="555" height="339" alt="Briefing-Document_Externally-Controlled-Trials" title="Briefing-Document_Externally-Controlled-Trials" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Using data from externally controlled trials in rare disease clinical development</h3> <div> <p>This briefing document describes external control arms and provides concise information on the FDA’s regulatory precedent regarding their acceptable use. It also summarizes the most salient recommendations for sponsors from the FDA’s Draft Guidance for Industry on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/an-innovative-approach-to-rare-disease-clinical-development" target="_self" title="Read the briefing"> Read the briefing </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="958b430c-b79c-4329-a94b-4d9c5fe2e25e"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 1x, https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg?crop=yes&w=555&h=339&a=0,0&itok=FQvai4kQ 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/elmxlvcjg9/web/ema-guideline-regulatory.jpg" width="555" height="339" alt="ema-guideline-regulatory" title="ema-guideline-regulatory" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>EMA guideline on computerised systems and electronic data in clinical trials</h3> <div> <p>This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/eu-ctr/ema-guideline-on-computerised-systems-and-electronic-data" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="ff9033cd-f5ac-465c-b324-a44b761f494e"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 1x, https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 1x, https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 1x, https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 1x, https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 1x, https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 1x, https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg?crop=yes&w=555&h=339&a=0,0&itok=AsoYkX2m 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/jrkimupc1q/web/uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology.jpg" width="555" height="339" alt="uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology" title="uuid_1986c031-b591-442d-9320-e4a83b628af1_dct-technology" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3> Navigating the regulatory labyrinth of technology in decentralised clinical trials</h3> <div> <p>This whitepaper discusses the varying regulatory and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.</p> </div> <a class="btn btn-primary btn-md" href="/insights/transforming-trials/decentralised-and-hybrid-clinical-trials/regulatory-labyrinth-of-technology" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="90475fc1-f53a-4e78-af11-258451b4ed54"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 1x, https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 1x, https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 1x, https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 1x, https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 1x, https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 1x, https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg?crop=yes&w=555&h=339&a=0,0&itok=c1B5Cwde 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/tje7crxjyv/web/orphan-drug-development-rarly-phase-to-maa.jpg" width="555" height="339" alt="orphan-drug-development-rarly-phase-to-maa" title="orphan-drug-development-rarly-phase-to-maa" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Navigating orphan drug development from early phase to marketing authorisation</h3> <div> <p>In this white paper, ICON’s experts discuss the intricacies of orphan drug development and the challenges that both the US and EU experience, including the EU concept of significant benefit criterion. </p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/navigating-orphan-drug-development" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="02b8a76c-699a-4fa1-9a97-20a0f4aa02b1"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 1x, https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg?crop=yes&w=555&h=339&a=0,0&itok=1hhelnig 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/ohjvfpjsvy/web/china-biotechs-insights.jpg" width="555" height="339" alt="china-biotechs-insights" title="china-biotechs-insights" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Procedural and regulatory know-how for China biotechs in the EU</h3> <div> <p>In this white paper, ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA, which allows the marketing authorisation holder to market a drug product in all European Union (EU) Member States, in addition, specific countries in European Economic Area (EEA), with a potential patient pool of approximately 500 million people. </p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/procedural-and-regulatory-know-how-for-china" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="25c61583-a6ba-4023-a9cf-32e00b7cb531"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 1x, https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 1x, https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 1x, https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 1x, https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 1x, https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 1x, https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=XGsOdcF6 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/3l8bk2odut/web/global-agency-meeting-whitepaper-555x339.jpg" width="555" height="339" alt="global-agency-meeting-whitepaper-555x339" title="global-agency-meeting-whitepaper-555x339" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Global agency meetings: A collaborative approach to drug development</h3> <div> <p>Read this briefing document to understand the specific consultation offerings, procedural steps, and timelines of regulatory agency meetings at various stages of drug development in the EU, US, Japan, China and Canada.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/global-agency-meetings" target="_self" title="Read the briefing"> Read the briefing </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="736d96b5-b12c-4619-ba90-a81b96ca2c76"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 1x, https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 1x, https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 1x, https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 1x, https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 1x, https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 1x, https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg?crop=yes&w=318&h=194&a=26,0&itok=DzyImQjY 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/79uoim1hno/web/EU-CTR_thumbnail-1-1.jpg" width="370" height="194" alt="EU-CTR_thumbnail-1-1" title="EU-CTR_thumbnail-1-1" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>European Union Clinical Trial Regulation</h3> <div> <p>The European Union Clinical Trial Regulation 536/2014 (EU CTR) introduces fundamental changes for interventional clinical trial submissions and approvals in all 30 countries of the European Union and the European Economic Area. The EU CTR has established a harmonised approach for clinical trial applications, assessment and reporting with consistent rules. Review our insights to understand the impact and strategic considerations for sponsors.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/eu-ctr" target="_self" title="Read our insights"> Read our insights </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="4021d379-37a5-428e-ae51-e6074ad56fb1"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 1x, https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 1x, https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 1x, https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 1x, https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 1x, https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 1x, https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg?crop=yes&w=257&h=157&a=22,0&itok=BPW5Vl29 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/1qfhv6j8lf/web/13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD.jpg" width="300" height="157" alt="13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD" title="13170-003-Publication-Marketing-Authorisation-Transfer-Web-Images-Homepage-2_MDD" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Transfer of marketing authorisation</h3> <div> <p>A successful MAT application is a very complex and cross-functional activity, involving many steps that require insightful planning and execution. Good teamwork, planning, and communication between all stakeholders including any clinical research organisations (CRO) that work for the seller or buyer are critical success factors. Read the whitepaper for best practices and clear guidance on transferring medical products.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/transfer-of-marketing-authorisation" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="05ccb728-259b-44b7-bf72-dfd5ca301073"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 1x, https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 1x, https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 1x, https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 1x, https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 1x, https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 1x, https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=oscK9kOa 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/zwa9gnscqn/web/keeping-the-end-in-mind-component.jpg" width="555" height="339" alt="keeping-the-end-in-mind-component" title="keeping-the-end-in-mind-component" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Keeping the end in mind: key considerations for creating plain language summaries</h3> <div> <p>For sponsors preparing to meet short deadlines for PLS submission, this whitepaper outlines considerations such as creating compliant templates, endpoint consistency and inclusion, and health literacy.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/keeping-the-end-in-mind-key-considerations-for-creating-plain-language-summaries" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="8165ecb1-7007-4d79-8a2a-908f8d14d496"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 1x, https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 1x, https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 1x, https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 1x, https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 1x, https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 1x, https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=iizw5smc 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/vnnpwjp6bb/web/requirements-strategy-component.jpg" width="555" height="339" alt="requirements-strategy-component" title="requirements-strategy-component" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Requirements & strategy considerations within clinical trial transparency</h3> <div> <p>Read the whitepaper to learn about current clinical trial disclosure (CTD) requirements, future regulatory changes, and strategies for planning for disclosure.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/requirements-strategy-considerations-within-clinical-trial-transparency" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="6a9fb652-029e-4845-b020-d224df1721bf"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 1x, https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 1x, https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 1x, https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 1x, https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 1x, https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 1x, https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg?crop=yes&w=555&h=339&a=0,0&itok=GyAQM0UW 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/zgzksmeoml/web/current-overview-of-data-sharing-component.jpg" width="555" height="339" alt="current-overview-of-data-sharing-component" title="current-overview-of-data-sharing-component" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Current overview of data sharing within clinical trial transparency</h3> <div> <p>Sponsors preparing to share their clinical documents can incorporate best practices and implementation recommendations presented in this whitepaper, including considerations for planning and basic data anonymisation strategies for protecting patient privacy while balancing data utility.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/current-overview-of-data-sharing-within-clinical-trial-transparency" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="4b8a612d-1510-4be7-b243-4af20599bd58"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 1x, https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 1x, https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 1x, https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 1x, https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 1x, https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 1x, https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg?crop=yes&w=555&h=339&a=0,0&itok=tOALK7HD 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/98o18wn2br/web/RACE-for-childrens-act-insights-image-555x339.jpg" width="555" height="339" alt="RACE-for-childrens-act-insights-image-555x339" title="RACE-for-childrens-act-insights-image-555x339" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>The RACE for Children Act</h3> <div> <p>Paediatric cancer is the leading cause of death by disease in the US. The intent of the RACE for Children Act is to get more paediatric oncology drugs in the pipeline.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/race-act" target="_self" title="Explore more updates on the RACE for Children Act"> Explore more updates on the RACE for Children Act </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="e3a62ce7-32ee-48f9-bcba-37f33ee82fd7"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 1x, https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 1x, https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 1x, https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 1x, https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 1x, https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 1x, https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg?crop=yes&w=555&h=339&a=0,0&itok=9gyWzhy6 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/7eqaaettul/web/thumbnail-journey-pvs-master-file.jpg" width="555" height="339" alt="thumbnail-journey-pvs-master-file" title="thumbnail-journey-pvs-master-file" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities</h3> <div> <p><strong>Ensuring regulatory compliance with the PSMF</strong></p> <p>It is essential that those who hold Marketing Authorisations (MA) within the European Economic Area have an established Pharmacovigilance System Master File (PSMF), which should be ready at the time of submission of all new applications for MAs. This whitepaper assesses the effectiveness of a global PSMF and its benefits to study personnel.</p> </div> <a class="btn btn-primary btn-md" href="/insights/patient-centricity/patient-safety-and-pharmacovigilance/pharmacovigilance-system-master-file-journey" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="29feb06f-d56f-4994-a216-81961ac6427a"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 1x, https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 1x, https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 1x, https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 1x, https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 1x, https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 1x, https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg?crop=yes&w=555&h=339&a=0,0&itok=Y8JevKe0 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/o3o9uyyo9n/web/Insights-article.jpg" width="555" height="339" alt="Insights-article" title="Insights-article" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Spotlight on regulatory reforms in China</h3> <div> <p>China’s regulatory reforms have attracted many foreign companies to conduct clinical trials and register their medicinal products in China. However, the evolving regulatory environment and country-specific requirements present significant challenges.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/spotlight-on-regulatory-reforms-in-china" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="121c7eca-aa1b-4d14-ad1d-9fb1038ed1d9"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 1x, https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 1x, https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 1x, https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 1x, https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 1x, https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 1x, https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg?crop=yes&w=622&h=380&a=409,0&itok=TZedpmML 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/3dqfcz8uhp/web/Whitepaper_Early-Engagement-Considerations-for-Biotech.jpg" width="1440" height="380" alt="Whitepaper_Early-Engagement-Considerations-for-Biotech" title="Whitepaper_Early-Engagement-Considerations-for-Biotech" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Early engagement and regulatory considerations for biotech</h3> <div> <p><strong>What companies must consider when developing an asset and the importance of regulatory strategy</strong></p> <p>Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/regulatory-considerations-for-biotech" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="926b15ea-f786-4486-a6e0-e7e70f96a1c0"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--picture-left-text-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 1x, https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 1x, https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 1x, https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 1x, https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 1x, https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 1x, https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg?crop=yes&w=318&h=194&a=26,0&itok=nv5NpFzA 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/wlafyqizea/web/Early-Scientific-Advice_370x194.jpg" width="370" height="194" alt="Early-Scientific-Advice_370x194" title="Early-Scientific-Advice_370x194" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6"> <div class="text-picture__text"> <h2></h2> <h3>Seeking parallel consultation from regulators and HTAs in Europe</h3> <div> <p>Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help. Read the whitepaper for key factors to ensure that parallel consultation meetings are well prepared, productive and informative.</p> </div> <a class="btn btn-primary btn-md" href="/insights/regulatory/eu-regulations/seeking-parallel-consultation-from-regulators-and-hta-bodies-in-EU" target="_self" title="Read the whitepaper"> Read the whitepaper </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="267861e1-9b84-43df-a614-4e596b1986f3"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper") }}> <div class="row"> <div class="col-sm"> <div class="text-picture text-left text-picture--text-left-picture-right text-left "> <div class="container-fluid container-fluid--xl"> <div class="row"> <div class="col-sm-6 order-sm-2"> <div class="text-picture__picture"> <div class="text-picture-link-wrapper"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 1x, https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 2x" media="(min-width: 1400px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 1x, https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 2x" media="(min-width: 1200px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 1x, https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 2x" media="(min-width: 992px) and (max-width: 1199px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 1x, https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 2x" media="(min-width: 768px) and (max-width: 991px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 1x, https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 2x" media="(min-width: 576px) and (max-width: 767px)" width="555" height="339"/> <source srcset="https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 1x, https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg?crop=yes&w=1111&h=679&a=0,0&itok=3RyjjuQW 2x" media="(max-width: 575px)" width="555" height="339"/> <img src="https://icon.widen.net/content/2r848mdoer/web/thumbnail-Regulatory%20intelligence%20Newsletter.jpg" width="1111" height="679" alt="thumbnail-Regulatory intelligence Newsletter" title="thumbnail-Regulatory intelligence Newsletter" loading="lazy" /> </picture> </div> </div> </div> </div> <div class="text-picture__picture-comment"> </div> </div> <div class="text-picture__text-wrapper col-sm-6 col-sm-pull-6"> <div class="text-picture__text"> <h2></h2> <h3>Global Regulatory Intelligence newsletter</h3> <div><p>Stay current on country, regional and global regulatory changes with ICON’s monthly Global Regulatory Intelligence Newsletter. It will keep you up to date with global regulatory changes that could impact your product.</p><p>Our experts review, interpret and summarise the latest regulatory developments so that you can spend more time taking your product to market. </p></div> <a class="btn btn-primary btn-md" href="/insights/regulatory/regulatory-intelligence-newsletter" target="_self" title="Subscribe to receive newsletter"> Subscribe to receive newsletter </a> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="d84a1f3e-c70c-4422-85e5-6e90dd1d6ac6"> <div class="group bg-transparent content-visibility--auto contain-intrinsic-size--400"> <div class="container-fluid container-fluid--xl"> <h2 class="group__title slick-carousel-title"> Regulatory media articles </h2> <div class="carousel--standard carousel--standard-1-3-3"> <a href="https://deep-dive.pharmaphorum.com/magazine/market-access-2021/nice-post-brexit-icon/" class="block-link carousel__item" target="_blank"> <div 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1x, https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=273&a=0,34&itok=djIrJboI 2x" media="(max-width: 575px)" width="545" height="286"/> <img class="card-img-top rounded-0" src="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=545&h=286&itok=qsXOkM9s" width="545" height="286" alt="regulatory-medical-device" title="regulatory-medical-device" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body"> <h4 class="card-title">How will NICE fare in a post-Brexit world?</h4> <div class="card-text small"> <div> <p>The impact of Brexit on the regulatory body, NICE, including NICE’s strong influence on the European market.</p> </div> </div> </div> </div> </div> </a> <a href="https://www2.iconplc.com/significant_role_regulatory_intelligence" class="block-link carousel__item" target="_self"> <div class="container-full"> <div class="card card--standard bg-white text-left"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=292&a=0,24&itok=UpUTg6fq 1x, https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=292&a=0,24&itok=aBSP6SFz 2x" media="(min-width: 1400px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=292&a=0,24&itok=UpUTg6fq 1x, https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=292&a=0,24&itok=aBSP6SFz 2x" media="(min-width: 1200px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=292&a=0,24&itok=UpUTg6fq 1x, https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=292&a=0,24&itok=aBSP6SFz 2x" media="(min-width: 992px) and (max-width: 1199px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=291&a=0,25&itok=HEbSA50D 1x, https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=154&a=0,93&itok=w_ydvYla 2x" media="(min-width: 768px) and (max-width: 991px)" width="162" height="85"/> <source srcset="https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=289&a=0,26&itok=9nuchJ1V 1x, https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=289&a=0,26&itok=nfCjz-Uk 2x" media="(min-width: 576px) and (max-width: 767px)" width="100" height="52"/> <source srcset="https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=545&h=286&itok=DYB5Iv40 1x, https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=555&h=273&a=0,34&itok=ioOpsUhC 2x" media="(max-width: 575px)" width="545" height="286"/> <img class="card-img-top rounded-0" src="https://icon.widen.net/content/5nimcpbhvt/web/female-medic-at-work.jpg?crop=yes&w=545&h=286&itok=DYB5Iv40" width="545" height="286" alt="female-medic-at-work" title="female-medic-at-work" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body"> <h4 class="card-title">The significant role of a robust regulatory intelligence process in global safety submissions</h4> <div class="card-text small"> <div> <p>Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety.</p> </div> </div> </div> </div> </div> </a> <a href="https://www.biocentury.com/article/631143" class="block-link carousel__item" target="_self"> <div class="container-full"> <div class="card card--standard bg-white text-left"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1407&h=740&a=17,0&itok=bqjRF7N_ 1x, https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1407&h=740&a=17,0&itok=CURxfO8c 2x" media="(min-width: 1400px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1407&h=740&a=17,0&itok=bqjRF7N_ 1x, https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1407&h=740&a=17,0&itok=CURxfO8c 2x" media="(min-width: 1200px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1407&h=740&a=17,0&itok=bqjRF7N_ 1x, https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1407&h=740&a=17,0&itok=CURxfO8c 2x" media="(min-width: 992px) and (max-width: 1199px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1410&h=740&a=15,0&itok=dAyYy499 1x, https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1440&h=400&a=0,170&itok=1W4LraLk 2x" media="(min-width: 768px) and (max-width: 991px)" width="162" height="85"/> <source srcset="https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1423&h=740&a=9,0&itok=XNGqRaWX 1x, https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1423&h=740&a=9,0&itok=vc8xB5Rw 2x" media="(min-width: 576px) and (max-width: 767px)" width="100" height="52"/> <source srcset="https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=545&h=286&itok=bs74DFBD 1x, https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=1440&h=708&a=0,16&itok=XXc-inTa 2x" media="(max-width: 575px)" width="545" height="286"/> <img class="card-img-top rounded-0" src="https://icon.widen.net/content/4ao00zb8zp/web/female-with-mask-avoiding-covid.jpg?crop=yes&w=545&h=286&itok=bs74DFBD" width="545" height="286" alt="female-with-mask-avoiding-covid" title="female-with-mask-avoiding-covid" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body"> <h4 class="card-title">What clinical holds and pauses mean for COVID-19 countermeasure timelines</h4> <div class="card-text small"> <div> <p>ICON’s Nuala Murphy and David Morse discuss trial pauses and clinical halts after three high-profile COVID-19 trials are temporarily halted as a result of potential safety issues.</p> </div> </div> </div> </div> </div> </a> <a href="https://www2.iconplc.com/article_MPN_june_2020" class="block-link carousel__item" target="_blank"> <div class="container-full"> <div class="card card--standard bg-white text-left"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=258&a=0,41&itok=gydqxpDF 1x, https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=258&a=0,41&itok=GoZ1zTQR 2x" media="(min-width: 1400px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=258&a=0,41&itok=gydqxpDF 1x, https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=258&a=0,41&itok=GoZ1zTQR 2x" media="(min-width: 1200px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=258&a=0,41&itok=gydqxpDF 1x, https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=258&a=0,41&itok=GoZ1zTQR 2x" media="(min-width: 992px) and (max-width: 1199px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=258&a=0,41&itok=DmBH2LUq 1x, https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=136&a=0,102&itok=Oal35h6z 2x" media="(min-width: 768px) and (max-width: 991px)" width="162" height="85"/> <source srcset="https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=255&a=0,43&itok=W7tCTNYI 1x, https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=255&a=0,43&itok=Gm1YSc6v 2x" media="(min-width: 576px) and (max-width: 767px)" width="100" height="52"/> <source srcset="https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=545&h=286&itok=admqg6eS 1x, https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=491&h=241&a=0,50&itok=GSHUrNzT 2x" media="(max-width: 575px)" width="545" height="286"/> <img class="card-img-top rounded-0" src="https://icon.widen.net/content/xfyndxmlbd/web/iPad-with-data-on-screen.jpg?crop=yes&w=545&h=286&itok=admqg6eS" width="545" height="286" alt="iPad-with-data-on-screen" title="iPad-with-data-on-screen" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body"> <h4 class="card-title">What manufacturers can learn from medical device regulation (MDR) preparations?</h4> <div class="card-text small"> <div> <p>ICON's Angela Brown considers what manufacturers can learn from medical device regulation (MDR) and the effect it will have on the in vitro diagnotic landscape (IVD).</p> </div> </div> </div> </div> </div> </a> <a href="https://www2.iconplc.com/top4challengesunderneweumdrivdr" class="block-link carousel__item" target="_blank"> <div class="container-full"> <div class="card card--standard bg-white text-left"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/ltljht12o4/web/regulatory.jpg?crop=yes&w=555&h=292&a=0,24&itok=IKzSGDjz 1x, https://icon.widen.net/content/ltljht12o4/web/regulatory.jpg?crop=yes&w=555&h=292&a=0,24&itok=d_97thRh 2x" media="(min-width: 1400px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/ltljht12o4/web/regulatory.jpg?crop=yes&w=555&h=292&a=0,24&itok=IKzSGDjz 1x, https://icon.widen.net/content/ltljht12o4/web/regulatory.jpg?crop=yes&w=555&h=292&a=0,24&itok=d_97thRh 2x" media="(min-width: 1200px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/ltljht12o4/web/regulatory.jpg?crop=yes&w=555&h=292&a=0,24&itok=IKzSGDjz 1x, https://icon.widen.net/content/ltljht12o4/web/regulatory.jpg?crop=yes&w=555&h=292&a=0,24&itok=d_97thRh 2x" media="(min-width: 992px) and (max-width: 1199px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/ltljht12o4/web/regulatory.jpg?crop=yes&w=555&h=291&a=0,25&itok=qmMow-P8 1x, 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</div> </div> <div class="card-body"> <h4 class="card-title">Challenges associated with new EU MDR and IVDR</h4> <div class="card-text small"> <div> <p>The key challenges associated with the new EU MDR and IVDR in this article in Med-Tech Innovation News.</p> </div> </div> </div> </div> </div> </a> <a href="https://www.massdevice.com/the-need-for-new-business-models-under-mdr-ivdr/" class="block-link carousel__item" target="_blank"> <div class="container-full"> <div class="card card--standard bg-white text-left"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=292&a=0,24&itok=0-2bnAvU 1x, https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=292&a=0,24&itok=9zRwNuJ2 2x" media="(min-width: 1400px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=292&a=0,24&itok=0-2bnAvU 1x, https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=292&a=0,24&itok=9zRwNuJ2 2x" media="(min-width: 1200px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=292&a=0,24&itok=0-2bnAvU 1x, https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=292&a=0,24&itok=9zRwNuJ2 2x" media="(min-width: 992px) and (max-width: 1199px)" width="270" height="142"/> <source srcset="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=291&a=0,25&itok=P-cMKAOC 1x, https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=154&a=0,93&itok=IDjoY2yi 2x" media="(min-width: 768px) and (max-width: 991px)" width="162" height="85"/> <source srcset="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=289&a=0,26&itok=7xt2-bon 1x, https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=289&a=0,26&itok=L1XIuLxW 2x" media="(min-width: 576px) and (max-width: 767px)" width="100" height="52"/> <source srcset="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=545&h=286&itok=uxSaHuOL 1x, https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=555&h=273&a=0,34&itok=4wacl_2l 2x" media="(max-width: 575px)" width="545" height="286"/> <img class="card-img-top rounded-0" src="https://icon.widen.net/content/rjpv8qm1ml/web/regulatory-medical-device.jpg?crop=yes&w=545&h=286&itok=uxSaHuOL" width="545" height="286" alt="regulatory-medical-device" title="regulatory-medical-device" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body"> <h4 class="card-title">The need for new business models under MDR/IVDR</h4> <div class="card-text small"> <div> <p>A thought leadership article on the approaching deadline for the new medical devices regulation (MDR) & in vitro diagnostic device regulation (IVDR).</p> </div> </div> </div> </div> </div> </a> </div> </div> </div> </div> <div id="66eddb1c-76ee-47ba-8994-bccca1a8d0fa"> <div class="container-fluid container-fluid--xl"> <div class="video-player video-player--with-playlist"> <video id="player-1701290598614260467" data-playlist-id="1701290598614260467" data-account="108289197001" data-player="default" data-embed="default" data-application-id="" class="video-js" controls=""> </video> <script src="//players.brightcove.net/108289197001/default_default/index.min.js"></script> <div class="vjs-playlist"></div> <script src="https://players.brightcove.net/videojs-bc-playlist-ui/3/videojs-bc-playlist-ui.min.js"></script> <script type="text/javascript"> videojs.getPlayer('player-1701290598614260467').ready(function() { // Get a reference to the player var myPlayer = this, // Create an object in which you will place options options = {}; // Set options options.horizontal = true; options.autoadvance = 0; // Call plugins method passing in options object myPlayer.bcPlaylistUi(options); }); </script> <div class="video-label"></div> </div> </div> </div> <div id="6e84bce4-b14f-4459-a71d-1eeed449b8ee"> <div class="group bg-white"> <div class="container-fluid container-fluid--xl"> <p class="group__text"> </p> <ul class="row card-list"> <li> <a href="/insights/blog/2024/06/04/navigating-regulatory-landscapes-guide-global-submission-standards" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-green-dark"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=RGEVEqNz 1x, https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=bhH9Nkg9 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=RGEVEqNz 1x, https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=bhH9Nkg9 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=BmbBq5Xt 1x, https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=227&h=157&a=37,0&itok=F6bGt7bF 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=300&h=157&a=0,0&itok=J6RwJidb 1x, https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=300&h=157&a=0,0&itok=CU2750v- 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=RowS7_0q 1x, https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=tNqJk2Bl 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=1iqKh9-F 1x, https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=pNiQ_n7a 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/aicondbnd0/web/blog-regulatory-submission-thumbnail-MDD.jpg?crop=yes&w=299&h=157&a=1,0&itok=1iqKh9-F" width="400" height="210" alt="blog-regulatory-submission-thumbnail-MDD" title="blog-regulatory-submission-thumbnail-MDD" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Navigating regulatory landscapes: A guide to global submission standards</h4> <div class="card-text small"> <div><p>This blog distils the key insights and recommendations shared in the webinar, offering a guide for pharmaceutical stakeholders navigating the complex terrain of regulatory submissions.</p></div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2024/07/19/streamlining-clinical-trial-submissions-under-eu-ctr" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=ilgEFtV3 1x, https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=zhh1UocK 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=ilgEFtV3 1x, https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=zhh1UocK 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=G8FVGglc 1x, https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=117&a=0,33&itok=OU2J3HhJ 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=aozjd-3w 1x, https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=W9GTCIBD 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=feF9xxXP 1x, https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=jqWu1CVC 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=Mgodt5xH 1x, https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=lNiEuByR 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/rfkxpgqvxa/web/MDR-certification-bottleneck-thumbnail?crop=yes&w=170&h=89&a=0,47&itok=Mgodt5xH" width="400" height="210" alt="MDR-certification-bottleneck-thumbnail" title="MDR-certification-bottleneck-thumbnail" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Streamlining early phase clinical trial submissions under the EU CTR</h4> <div class="card-text small"> <div><p>To ensure a swift and efficient submission process under the EU CTR, ICON has implemented several key strategies to support clinical research organisations through the approval process. Learn more.</p></div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2024/07/10/defining-differences-when-regulating-medical-devices-medicinal-and" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=mutZaPjg 1x, https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=dtq0uMAW 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=mutZaPjg 1x, https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=dtq0uMAW 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=Y5Qe1iI- 1x, https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=249&a=0,56&itok=5Yotwp6N 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=188&a=0,86&itok=RMgfowko 1x, https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=188&a=0,86&itok=eg9xXhrn 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=c5uC1N0m 1x, https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=pzjDtL-K 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=9QIfgidF 1x, https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=zgsDKb1c 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/9arkl7wjn8/web/Covid-PV-Blog-Image.jpg?crop=yes&w=360&h=189&a=0,86&itok=9QIfgidF" width="400" height="210" alt="Covid-PV-Blog-Image" title="Covid-PV-Blog-Image" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Defining the differences when regulating medical devices, medicinal and combination products</h4> <div class="card-text small"> <div><p>Clinical trial and healthcare regulations are notoriously complex, blurring boundaries between the medicinal products and medical devices resulting in the classifications of these products becoming ever more complicated. Read more.</p></div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2022/12/16/the-impact-of-RWE-on-drug-marketing-approval-and-reimbursement" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-green-dark"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=8uH8ITRL 1x, https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=6wpoYMLT 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=8uH8ITRL 1x, https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=6wpoYMLT 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=IvaAybIQ 1x, https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=138&a=0,39&itok=F9WufCGO 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=104&a=0,56&itok=0sJ0ALB2 1x, https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=104&a=0,56&itok=CKZeuadd 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=w-cAhoWZ 1x, https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=5pvDcD8U 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=CZTmJSKe 1x, https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=nzKJGqwU 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/arxx3rqofy/web/blog-the-impact-of-RWD-thumbnail.png?crop=yes&w=200&h=105&a=0,56&itok=CZTmJSKe" width="400" height="210" alt="blog-the-impact-of-RWD-thumbnail" title="blog-the-impact-of-RWD-thumbnail" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">The impact of real world evidence on drug marketing approval and reimbursement</h4> <div class="card-text small"> <div> <p>Increasing use of real world data and real world evidence for market regulatory decisions can lead to a more holistic understanding of safety and potency factors for healthcare practices.</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2022/11/29/medical-device-classification-and-applicable-FDA-regulations" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-green-dark"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=UqzrTALN 1x, https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=BrqQWZtq 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=UqzrTALN 1x, https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=BrqQWZtq 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=FT_v_AEQ 1x, https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=117&a=0,33&itok=wSz6CXzR 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=1diqfUbX 1x, https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=CZbWi4eY 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=HViSFmUc 1x, https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=azdMinNz 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=SIsiyIqu 1x, https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=5ugFvaLh 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/5vr60oulzb/web/medical-device-classifications-blog?crop=yes&w=170&h=89&a=0,47&itok=SIsiyIqu" width="400" height="210" alt="medical-device-classifications-blog" title="medical-device-classifications-blog" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Medical device classifications and applicable Food and Drug Administration regulations</h4> <div class="card-text small"> <div> <p>Medical device manufacturers should understand how their product is viewed by regulatory bodies to proceed with the appropriate regulatory pathway to market. </p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2022/01/20/progressive-ivdr-rollout-made-official" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=wh41InJP 1x, https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=gZgwcfqM 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=wh41InJP 1x, https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=gZgwcfqM 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=c6ZWzx34 1x, https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=117&a=0,27&itok=_DwgqYR5 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=-cTAiM1S 1x, https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=b96kUQ-H 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=nRyuhpYY 1x, https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=4CEA74vs 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=8osJVjoY 1x, https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=1QjH69A4 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/5d9rztxxcp/web/IVDR-Blog-thumbnail.png?crop=yes&w=170&h=89&a=0,41&itok=8osJVjoY" width="400" height="210" alt="IVDR-Blog-thumbnail" title="IVDR-Blog-thumbnail" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Progressive IVDR rollout made official</h4> <div class="card-text small"> <div> <p>As of 15 December 2021, the European Parliament and the European Council have adopted their proposal to make the suggested progressive IVDR rollout timeline official.</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2021/08/06/assessing-the-need-for-primary-supporting-clinical-evidence-or-post-market-clinical-follow-up-under-mdr" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=Q__LlH6c 1x, https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=9bVZXAFo 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=Q__LlH6c 1x, https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=9bVZXAFo 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=CHzoQhRI 1x, https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=256&a=0,57&itok=dB9pjTxv 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=193&a=0,89&itok=i7DkqPkY 1x, https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=193&a=0,89&itok=mMRLXrug 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=Gqafvanz 1x, https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=NMl3BNPO 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=TCTjoCRG 1x, https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=UA9KNozf 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/fflexp6s3u/web/MDDR-blog_tile-image.jpg?crop=yes&w=370&h=194&a=0,88&itok=TCTjoCRG" width="400" height="210" alt="MDDR-blog_tile-image" title="MDDR-blog_tile-image" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Assessing the need for primary supporting clinical evidence or post-market clinical follow-up under MDR</h4> <div class="card-text small"> <div> <p>Discover why identifying the study objective during the planning process for PMCF studies is a critical step in the transition to MDR.</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2021/04/02/event-report-dia-europe-2021" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=OGtlhVOi 1x, https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=p736hk2D 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=OGtlhVOi 1x, https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=p736hk2D 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=TNCjFAAt 1x, https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=256&a=0,57&itok=yTxHivsI 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=193&a=0,89&itok=CM0mOMin 1x, https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=193&a=0,89&itok=3oV4L4RB 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=9svUVLnm 1x, https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=M51D4dzn 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=Tiahdmcv 1x, https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=Mo0NO291 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/hmc7zsdcik/web/colleagues-in-a-meeting.jpg?crop=yes&w=370&h=194&a=0,88&itok=Tiahdmcv" width="400" height="210" alt="colleagues-in-a-meeting" title="colleagues-in-a-meeting" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Event report - DIA Europe 2021: Advancing health priorities</h4> <div class="card-text small"> <div> <p>Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2020/08/20/iso-14155-medical-device-regulations" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=QK7mkcWo 1x, https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=gIddE1-l 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=QK7mkcWo 1x, https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=gIddE1-l 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=HwTGe0GJ 1x, https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=256&a=0,57&itok=BpAFcBey 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=193&a=0,89&itok=fV-woDvB 1x, https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=193&a=0,89&itok=9PEushNX 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=zi4rIx-K 1x, https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=ptG_jo0x 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=uZlF5ZoF 1x, https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=KCnWvq16 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/zydzbztbil/web/doctor-with-tablet.jpg?crop=yes&w=370&h=194&a=0,88&itok=uZlF5ZoF" width="400" height="210" alt="doctor-with-tablet" title="doctor-with-tablet" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">ISO 14155: Increased emphasis on clinical data continues to trend for medical device regulations</h4> <div class="card-text small"> <div> <p>Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2020/09/16/new-uk-conformity-assessed-marking" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=FPNxI_Aw 1x, https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=fptNlOkG 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=FPNxI_Aw 1x, https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=fptNlOkG 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=55jVBBqC 1x, https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=145&a=0,33&itok=6DvOfI15 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=8ULil5_X 1x, https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=SAYSAZDf 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=-X0ge4mH 1x, https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=-qJBd3Kg 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=HuHyqPno 1x, https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=wQgQF_Y8 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/vgdnjcxnjs/web/UKCA-square-thumbnail.jpg?crop=yes&w=210&h=110&a=0,50&itok=HuHyqPno" width="400" height="210" alt="UKCA-square-thumbnail" title="UKCA-square-thumbnail" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">New UKCA (UK Conformity Assessed) marking</h4> <div class="card-text small"> <div> <p>The Medicines and Healthcare products Regulatory Agency (MHRA) recently published new guidance on how it will regulate medical devices starting in January 2021.<br>  </p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2020/01/14/changes-in-clinical-safety-reporting-to-us-fda" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=JeedizcB 1x, https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=nrMu_Nka 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=JeedizcB 1x, https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=nrMu_Nka 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=CuxenWne 1x, https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=256&a=0,57&itok=LK0A3gNq 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=193&a=0,89&itok=xLp33Xjx 1x, https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=193&a=0,89&itok=U2CNfGEH 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=_-DI8pJx 1x, https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=iVbxljgt 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=Lje4OKzQ 1x, https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=S3AY3p0e 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/pffgsbcayw/web/medical-devices-and-charts.jpg?crop=yes&w=370&h=194&a=0,88&itok=Lje4OKzQ" width="400" height="210" alt="medical-devices-and-charts" title="medical-devices-and-charts" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">Changes in clinical safety reporting to the FDA</h4> <div class="card-text small"> <div> <p>FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies.</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2020/04/27/the-shifting-diagnostics-regulatory-landscape-amid-COVID-19" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=IAftHAK4 1x, https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=5OsWDQX4 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=IAftHAK4 1x, https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=5OsWDQX4 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=s4of586f 1x, https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=117&a=0,27&itok=5INJ2ozI 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=TZRcNJOS 1x, https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=YFWitikL 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=IR_uGUgG 1x, https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=j-1oJCpr 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=11tOq92D 1x, https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=gED-lJrL 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/bduy8ofvwz/web/8001-Covid-19-Diagnostics-Web-170x170.jpg?crop=yes&w=170&h=89&a=0,41&itok=11tOq92D" width="400" height="210" alt="8001-Covid-19-Diagnostics-Web-170x170" title="8001-Covid-19-Diagnostics-Web-170x170" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">The shifting diagnostics regulatory landscape amid COVID-19</h4> <div class="card-text small"> <div> <p>For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.<br>  </p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2019/10/31/mdr-ivdr-regulatory-roundup" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=aU_OcGor 1x, https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=Tece-Kmo 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=aU_OcGor 1x, https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=Tece-Kmo 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=7GdhquOp 1x, https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=227&h=157&a=37,0&itok=uiKm451B 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=300&h=157&a=0,0&itok=oJ3gZUYY 1x, https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=300&h=157&a=0,0&itok=VZEqTynC 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=veWVHJKm 1x, https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=ldhUxlSI 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=qF-ZXTNN 1x, https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=JBCQRZZ6 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/f19cvat8ic/web/uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu.jpg?crop=yes&w=299&h=157&a=1,0&itok=qF-ZXTNN" width="400" height="210" alt="uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu" title="uuid_d1cef1f9-9f9c-4ebb-a868-1a991b0bb975_mdr-eu" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">MDR/IVDR regulatory round-up</h4> <div class="card-text small"> <div> <p>To ensure compliance under MDR and IVDR, manufacturers should act quickly to identify and secure a notified body (NB). Manufacturers should evaluate expertise and resources to determine which NBs are the best fit for their products</p> </div> </div> </div> </div> </a> </li> <li> <a href="/insights/blog/2020/04/03/covid-19-and-respiratory-devices" class="block-link" target="_self"> <div class="card card--overlapping-img text-left card--overlapping-img-blue"> <div class="image image--zoom-on-hover"> <div> <div> <picture> <source srcset="https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=xDDjmTt0 1x, https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=iwYgDMj7 2x" media="(min-width: 1400px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=xDDjmTt0 1x, https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=iwYgDMj7 2x" media="(min-width: 1200px)" width="370" height="194"/> <source srcset="https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=rBWx0s48 1x, https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=117&a=0,27&itok=gbFfbwFh 2x" media="(min-width: 992px) and (max-width: 1199px)" width="301" height="158"/> <source srcset="https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=39FGItX5 1x, https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=KCZIDKLu 2x" media="(min-width: 768px) and (max-width: 991px)" width="226" height="118"/> <source srcset="https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=KElF8R1y 1x, https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=lV4Q9qXe 2x" media="(min-width: 576px) and (max-width: 767px)" width="400" height="210"/> <source srcset="https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=Dqc_IIci 1x, https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=uEqDJc9r 2x" media="(max-width: 575px)" width="400" height="210"/> <img src="https://icon.widen.net/content/lxmoerllpn/web/Respiratory-device-blog-thumbnail.jpg?crop=yes&w=170&h=89&a=0,41&itok=Dqc_IIci" width="400" height="210" alt="Respiratory-device-blog-thumbnail" title="Respiratory-device-blog-thumbnail" loading="lazy" /> </picture> </div> </div> </div> <div class="card-body overlapping-comp" data-mh="card-body"> <i aria-hidden="true" class="icon-ui-arrow-right"></i> <h4 class="card-title">COVID-19 and respiratory devices: A dynamic market and evolving regulations</h4> <div class="card-text small"> <div> <p>The respiratory devices market is witnessing enormous demands across the globe, resulting from the increased need for ventilators due to rising COVID-19 cases.</p> </div> </div> </div> </div> </a> </li> </ul> </div> </div> </div> <div id="803e1ccd-cacc-43ac-8b54-593350fad25f"> <div class="group group--with-carousel bg-white content-visibility--auto contain-intrinsic-size--400 related-content-carousel"> <div class="container-fluid container-fluid--xl"> <div class="carousel--standard carousel--standard-1-3-4"> <a class="carousel__item block-link" href="http://www2.iconplc.com/casestudy/mddr/regulatoryclearance" target="_self"> <div class="card card--with-solid-bg card--with-solid-bg-purple" data-mh="related-content"> <div class="card-body"> <i 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