{"id":5760,"date":"2023-09-27T08:37:11","date_gmt":"2023-09-27T08:37:11","guid":{"rendered":"https:\/\/dev-ubc-new.pantheonsite.io\/?page_id=5760"},"modified":"2025-10-17T20:35:11","modified_gmt":"2025-10-17T20:35:11","slug":"risk-evaluation-mitigation-strategies","status":"publish","type":"page","link":"https:\/\/ubc.com\/solution\/safety-risk-management\/risk-evaluation-mitigation-strategies\/","title":{"rendered":"Risk Evaluation &#038; Mitigation Strategies"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5760\" class=\"elementor elementor-5760\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-55c90cb0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"55c90cb0\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3e5f8d0a\" data-id=\"3e5f8d0a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-70cad00b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"70cad00b\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-4435eb60\" data-id=\"4435eb60\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-13c647db elementor-widget elementor-widget-text-editor\" data-id=\"13c647db\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Risk Evaluation &amp; Mitigation Strategies<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a79e02b elementor-widget-tablet__width-initial elementor-widget elementor-widget-heading\" data-id=\"5a79e02b\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Positively Impact and Manage Your Product\u2019s\nSafety <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-106774ab elementor-widget elementor-widget-text-editor\" data-id=\"106774ab\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Market-efficient strategies to manage risks and regulatory obligations.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-232df6dd\" data-id=\"232df6dd\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-70acee05 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"70acee05\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-529cb915\" data-id=\"529cb915\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5bd1fb2c aboutusBreadcrumb elementor-widget elementor-widget-html\" data-id=\"5bd1fb2c\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<nav aria-label=\"breadcrumb\">\n  <ol class=\"breadcrumb\">\n    <li class=\"breadcrumb-item\"><a href=\"\/\"><img decoding=\"async\" src=\"\/wp-content\/uploads\/2023\/09\/home-line.svg\"\/><\/a><\/li>\n    <li class=\"breadcrumb-item\">Solutions<\/li>\n    <li class=\"breadcrumb-item active\" aria-current=\"page\"><a href=\"\/solution\/safety-risk-management\/\" >Safety  & Risk Management <\/a><\/li>\n    <li class=\"breadcrumb-item active\" aria-current=\"page\">Risk Evaluation & Mitigation Strategies<\/li>\n  <\/ol>\n<\/nav>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6085e0c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6085e0c\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ed707db\" data-id=\"ed707db\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-2e068712 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2e068712\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-59b6f310\" data-id=\"59b6f310\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4b7d871c elementor-widget elementor-widget-heading\" data-id=\"4b7d871c\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Fulfill Your Regulatory Obligations With Confidence<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e2f309d elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"e2f309d\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Regulatory requirements for new and existing products can be complex and require proven methods, extensive knowledge, and technical expertise. A trusted partner who can provide guidance on meeting FDA mandates to ensure the benefits of a drug or biologic product outweigh its risk can make all the difference.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-58f93d81 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"58f93d81\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-5c8a7323\" data-id=\"5c8a7323\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6422b114 elementor-widget elementor-widget-heading\" data-id=\"6422b114\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">REMS Consulting &amp; Design<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3cdff66f elementor-widget elementor-widget-text-editor\" data-id=\"3cdff66f\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Whether a REMS plan is on the horizon, or you are currently in discussion with the FDA, UBC offers consulting on all aspects of your REMS program and FDA interactions. Regardless of your timing requirements, we can partner at any point to review product benefit and risk, provide REMS design options, and ensure you are ready for REMS discussions as you move through product development and approval.<\/p><p>With over 150 years of combined industry experience rooted in evidence generation, our REMS consultants provide strategic guidance to support customers in securing the safe and appropriate use of their products. The UBC epidemiology-led approach supports regulatory authority interactions regarding effective strategies for mitigating specific product risks.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-1680d1e1\" data-id=\"1680d1e1\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e4b30b elementor-widget elementor-widget-spacer\" data-id=\"3e4b30b\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b7718e7 elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b7718e7\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-145342c\" data-id=\"145342c\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-facf725 elementor-widget elementor-widget-spacer\" data-id=\"facf725\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-d72c9a9\" data-id=\"d72c9a9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7121aa2 elementor-widget elementor-widget-heading\" data-id=\"7121aa2\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">REMS Implementation &amp; Evaluation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ee2ca3 elementor-widget elementor-widget-text-editor\" data-id=\"3ee2ca3\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Partner with a trusted advisor for full-service REMS delivery<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0262774 elementor-widget elementor-widget-text-editor\" data-id=\"0262774\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>With experience delivering more than 120 risk management programs across multiple therapeutic areas with varied risks, UBC is the leading provider of integrated, comprehensive REMS services. Guided by our team of epidemiologists, safety scientists, clinicians, data analysts, software developers, statisticians, psychometricians, and project managers, UBC has established a reputation among sponsors and the FDA as the leader in full-service REMS delivery.<\/p><ul><li>REMS Implementation<\/li><li>UBC Knowledge Survey System<\/li><li>Coordinating Center Operations (REMS Center of Excellence)<\/li><li>REMS Evaluation<\/li><li>FDA Assessment Report Analysis and Preparation<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-40a88c9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"40a88c9\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ce4c24f\" data-id=\"ce4c24f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d0c303e elementor-widget elementor-widget-heading\" data-id=\"d0c303e\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Configurable, Scalable Solutions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e73431 elementor-widget elementor-widget-text-editor\" data-id=\"8e73431\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>When a multi-sponsor REMS consortium is required, it is important to establish consensus on imperatives among the sponsors comprising the single, shared system REMS. <span data-teams=\"true\">By applying UBC&#8217;s deep REMS experience in conjunction with the project management organization<br \/>(PMO) offering, customers benefit from a centralized approach ensuring both consortium and individual company requirement consideration in a professional, confidential, and fiscally responsible manner.<\/span><\/p><p>UBC as PMO:<\/p><ul><li>Governance &amp; Program Charter<\/li><li>Sponsor &amp; Third-party Vendor Onboarding<\/li><li>Regulatory Reporting Oversight<\/li><li>Document Repository Management<\/li><li>Financial Planning &amp; Management<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-5c0cefc\" data-id=\"5c0cefc\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed5be5e elementor-widget elementor-widget-spacer\" data-id=\"ed5be5e\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-52a7b46b elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"52a7b46b\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9650500\" data-id=\"9650500\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6e86acb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6e86acb\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-a796eed\" data-id=\"a796eed\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-76b5eca elementor-widget elementor-widget-heading\" data-id=\"76b5eca\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">REMS Experience<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-45de6b9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"45de6b9\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-5045babd\" data-id=\"5045babd\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-99bc616 remsExperience elementor-widget elementor-widget-counter\" data-id=\"99bc616\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">Administrator for over 50% of active REMS with 1 to 6 Elements to Assure Safe Use<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"50\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\">%<\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-19598ead\" data-id=\"19598ead\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-55b27bdc elementor-widget elementor-widget-counter\" data-id=\"55b27bdc\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">More than 18,000 Knowledge, Attitude &amp; Behavior Surveys completed<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"18000\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\"><\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-6cd5a0ed\" data-id=\"6cd5a0ed\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-227ae986 elementor-widget elementor-widget-counter\" data-id=\"227ae986\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">Over 100 REMS Assessment Reports submitted to FDA<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"100\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\">+<\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-9cf3585\" data-id=\"9cf3585\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-33fff657 elementor-widget elementor-widget-counter\" data-id=\"33fff657\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">25,000+ REMS Coordinating Center calls per month with 88% of inbound calls answered in &lt;30 seconds<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"25000\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\">+<\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-203e2dc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"203e2dc\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b1dddf5\" data-id=\"b1dddf5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-02bb4d2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"02bb4d2\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-a478802\" data-id=\"a478802\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cc5e62d elementor-widget elementor-widget-heading\" data-id=\"cc5e62d\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">EU Risk Management Plans &amp; Effectiveness Evaluations<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1674f60 elementor-widget elementor-widget-text-editor\" data-id=\"1674f60\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Your guide to understanding, evaluating, and mitigating product risk<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb4bdb2 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"fb4bdb2\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>With an increasing regulatory focus on the importance of evaluating the effectiveness of risk minimization activities, UBC is uniquely skilled at<br \/>designing and implementing evaluation studies with maximum efficiency and minimal burden to healthcare professionals, patients, and sponsors.<\/p><p>UBC is unequaled in its mastery of Risk Management Plan (RMP) requirements, leveraging experts who have created complex RMPs, not only in the EU, but also in other territories worldwide where an RMP is required for regulatory approval. We are well-versed in local regulatory requirements, and we understand the nuances of these regulations and how RMP content is interpreted. UBC partners with you to develop an RMP that will meet regulatory expectations and<br \/>minimize questions during the regulatory review period.<\/p><p><strong>EU Risk Management Services:<\/strong><\/p><ul><li>Developmental RMPs<\/li><li>Assessment of Effectiveness of Additional Risk Minimization Measures (aRMMs)<\/li><li>RMPs for Regulatory Submission<\/li><li>Protocol Development for Post-Authorization Safety Studies<\/li><li>Risk Minimization Activities and Educational Materials<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e1fec59 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"e1fec59\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-74d1557\" data-id=\"74d1557\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7cf94fd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7cf94fd\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-e4f183d\" data-id=\"e4f183d\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-33f3f55 elementor-widget elementor-widget-heading\" data-id=\"33f3f55\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">EU Risk Management Experience<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca94b5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7ca94b5\" data-element_type=\"section\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-e1afff5\" data-id=\"e1afff5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-58b3598 elementor-widget elementor-widget-counter\" data-id=\"58b3598\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">14+ years of experience<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"14\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\">+<\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-363bc71\" data-id=\"363bc71\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5bd8786 elementor-widget elementor-widget-counter\" data-id=\"5bd8786\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">More than 70 EU RMPs<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"70\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\">+<\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-2a668e8\" data-id=\"2a668e8\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-de82c55 elementor-widget elementor-widget-counter\" data-id=\"de82c55\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">Over 20 RMPs for countries outside of the EU<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"20\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\">+<\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-cb57c07\" data-id=\"cb57c07\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-85faf32 elementor-widget elementor-widget-counter\" data-id=\"85faf32\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"counter.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-counter\">\n\t\t\t<div class=\"elementor-counter-title\">44 indications supported<\/div>\t\t\t<div class=\"elementor-counter-number-wrapper\">\n\t\t\t\t<span class=\"elementor-counter-number-prefix\"><\/span>\n\t\t\t\t<span class=\"elementor-counter-number\" data-duration=\"2000\" data-to-value=\"44\" data-from-value=\"0\" data-delimiter=\",\">0<\/span>\n\t\t\t\t<span class=\"elementor-counter-number-suffix\">+<\/span>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3ec1c26b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3ec1c26b\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-75979ef\" data-id=\"75979ef\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-19705b8a elementor-widget elementor-widget-heading\" data-id=\"19705b8a\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Learn More About UBC's REMS<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-755d739e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"755d739e\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Interested in learning more about how UBC\u2019s REMS can help you make more informed decisions earlier and meet regulatory requirements?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-94218ec elementor-align-center elementor-widget elementor-widget-button\" data-id=\"94218ec\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/ubc.com\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact Us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Risk Evaluation &amp; Mitigation Strategies Positively Impact and Manage Your Product\u2019s Safety Market-efficient strategies to manage risks and regulatory obligations. Solutions Safety &#038; Risk Management Risk Evaluation &#038; Mitigation Strategies Fulfill Your Regulatory Obligations With Confidence Regulatory requirements for new and existing products can be complex and require proven methods, extensive knowledge, and technical expertise. 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