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The Role of Confirmatory Trials After Accelerated Approval			</a></h3><div class="uael-post__separator"></div><div class="uael-post__excerpt"><p>Initially developed for the HIV/AIDS crisis in 1992, the US Food and Drug Administration (FDA) established the accelerated approval program to expedite the approval of &#8230;</p></div><div class="uael-post__meta-data">
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Rethinking Statistical Significance in a Rare<br>Disease Context			</a></h3><div class="uael-post__separator"></div><div class="uael-post__excerpt"><p>Highlights of a recent panel debate moderated by Christian K Schneider, head of Biopharma Excellence, reviewing emerging approaches to clinical data collection where patient populations &#8230;</p></div><div class="uael-post__meta-data">
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Data Protection and Clinical Trial			</a></h3><div class="uael-post__separator"></div><div class="uael-post__excerpt"><p>The highly regulated nature of the pharmaceutical industry means that organisations within this sector are no strangers to the requirement to abide by the various &#8230;</p></div><div class="uael-post__meta-data">
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The Year Ahead for Life Sciences Regulatory<br>Operations			</a></h3><div class="uael-post__separator"></div><div class="uael-post__excerpt"><p>Amplexor asked some of its closest partners for their views on the most important developments in Life Sciences regulatory operations in 2022, and for their &#8230;</p></div><div class="uael-post__meta-data">
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Beyond modernisation– Unlocking the Value<br>of Regulatory Information Management			</a></h3><div class="uael-post__separator"></div><div class="uael-post__excerpt"><p>Biopharmaceutical companies are now at an important inflexion point. Most have completed their modernisation of the Regulatory function globally, bringing improvements to efficiency, according to &#8230;</p></div><div class="uael-post__meta-data">
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<span class="uael-heading-text elementor-inline-editing uael-size--default" data-elementor-setting-key="heading_title" data-elementor-inline-editing-toolbar="basic">Current Edition</span></h2></div></div></div></div></div><div class="elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-35629a82 elementor-hidden-mobile" data-id="35629a82" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-7d3ef558 uael-tablet-heading-align-center elementor-widget elementor-widget-uael-advanced-heading" data-id="7d3ef558" data-element_type="widget" data-widget_type="uael-advanced-heading.default"><div class="elementor-widget-container"><div class="uael-module-content uael-heading-wrapper"><h2 class="uael-heading">
<span class="uael-heading-text elementor-inline-editing uael-size--default" data-elementor-setting-key="heading_title" data-elementor-inline-editing-toolbar="basic">Current Features</span></h2></div></div></div></div></div></div></section><section class="elementor-section elementor-top-section elementor-element elementor-element-a19940a elementor-hidden-desktop elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="a19940a" data-element_type="section"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-687d9e11" data-id="687d9e11" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-d1cc192 elementor-grid-1 elementor-grid-tablet-1 elementor-widget__width-initial elementor-posts--thumbnail-top elementor-grid-mobile-1 elementor-widget elementor-widget-posts" data-id="d1cc192" data-element_type="widget" data-settings="{&quot;custom_columns&quot;:&quot;1&quot;,&quot;custom_columns_tablet&quot;:&quot;1&quot;,&quot;custom_columns_mobile&quot;:&quot;1&quot;,&quot;custom_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:35,&quot;sizes&quot;:[]},&quot;custom_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;custom_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}" data-widget_type="posts.custom"><div class="elementor-widget-container"><div class="ecs-posts elementor-posts-container elementor-posts   elementor-grid elementor-posts--skin-custom" data-settings="{&quot;current_page&quot;:1,&quot;max_num_pages&quot;:&quot;5&quot;,&quot;load_method&quot;:&quot;&quot;,&quot;widget_id&quot;:&quot;d1cc192&quot;,&quot;post_id&quot;:17979,&quot;theme_id&quot;:17979,&quot;change_url&quot;:false,&quot;reinit_js&quot;:false}"><article id="post-22395" class="elementor-post elementor-grid-item ecs-post-loop post-22395 archived_issues type-archived_issues status-publish hentry date-1873"><div data-elementor-type="loop" data-elementor-id="42" class="elementor elementor-42 post-22395 archived_issues type-archived_issues status-publish hentry date-1873"><section class="elementor-section elementor-top-section elementor-element elementor-element-219d2859 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="219d2859" data-element_type="section"><div class="elementor-container elementor-column-gap-default"><div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4902031b" data-id="4902031b" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-bfe9cc8 elementor-widget elementor-widget-image" data-id="bfe9cc8" data-element_type="widget" data-widget_type="image.default"><div class="elementor-widget-container">
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<img data-lazyloaded="1" src="data:image/svg+xml;base64,PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIyMjAiIGhlaWdodD0iMzA0IiB2aWV3Qm94PSIwIDAgMjIwIDMwNCI+PHJlY3Qgd2lkdGg9IjEwMCUiIGhlaWdodD0iMTAwJSIgZmlsbD0iI2NmZDRkYiIvPjwvc3ZnPg==" width="220" height="304" decoding="async" data-src="https://journalforclinicalstudies.com/wp-content/uploads/elementor/thumbs/JCS-Spring-2023-cover-q48ebilghvx6bev2y7cu3dvvjcpa4rn4mktmseaoyo.png" title="JCS Spring 2023 cover" alt="JCS Spring 2023 cover" loading="lazy" />								</a></div></div></div></div></div></section></div></article></div></div></div></div></div><div class="elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-2743adb" data-id="2743adb" data-element_type="column"><div class="elementor-widget-wrap elementor-element-populated"><div class="elementor-element elementor-element-592dd9b uael-tablet-heading-align-center elementor-hidden-tablet elementor-widget elementor-widget-uael-advanced-heading" data-id="592dd9b" data-element_type="widget" data-widget_type="uael-advanced-heading.default"><div class="elementor-widget-container"><div class="uael-module-content uael-heading-wrapper"><h2 class="uael-heading">
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