What We Do - Global Patient Safety

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class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Clinical Trials Overview" menu-type="header" data-value="FLItem-4-SLItem-14-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/clinical-trials/about-clinical-trials" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="About Clinical Trials" menu-type="header" data-value="FLItem-4-SLItem-14-SLItem-2"> About Clinical Trials </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="https://www.amgentrials.com" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Amgen Clinical Trials" menu-type="header" rel="noopener" data-value="FLItem-4-SLItem-14-SLItem-3"> Amgen Clinical Trials<i class="fa fa-external-link"></i> </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/clinical-trials/clinical-trial-diversity" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Clinical Trial Diversity" menu-type="header" data-value="FLItem-4-SLItem-14-SLItem-4"> Clinical Trial Diversity and Representation </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/clinical-trials/information-for-healthcare-professionals" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Information for Healthcare Professionals" menu-type="header" data-value="FLItem-4-SLItem-14-SLItem-5"> Information for Healthcare Professionals </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/clinical-trials/clinical-data-transparency-practices" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Clinical Trial Transparency Data Sharing and Disclosures Practices" menu-type="header" data-value="FLItem-4-SLItem-14-SLItem-6"> Clinical Trial Transparency, Data Sharing and Disclosure Practices </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/clinical-trials/clinical-out-of-hours-support-program" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Clinical Out of Hours Support Program" menu-type="header" data-value="FLItem-4-SLItem-14-SLItem-7"> Clinical Out-of-Hours Support program </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="http://www.amgeniss.com" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Investigator Sponsored Activities" menu-type="header" rel="noopener" data-value="FLItem-4-SLItem-14-SLItem-8"> Investigator Sponsored Studies<i class="fa fa-external-link"></i> </a> </li> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/science/scientific-community-initiatives" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " class="hide-href" menu-name="Scientific Community Initiatives" menu-type="header" data-value="FLItem-4-SLItem-15"> Scientific Community Initiatives    </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/scientific-community-initiatives" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Scientific Community Initiatives Overview" menu-type="header" data-value="FLItem-4-SLItem-15-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/scientific-community-initiatives/educational-outreach-program" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Educational Outreach Program" menu-type="header" data-value="FLItem-4-SLItem-15-SLItem-2"> Educational Outreach Program </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/scientific-community-initiatives/postdoctoral-fellows" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Postdoctoral Fellows Program" menu-type="header" data-value="FLItem-4-SLItem-15-SLItem-3"> Postdoctoral Fellows Program </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/scientific-community-initiatives/scientific-conferences-program" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Scientific Conferences Program" menu-type="header" data-value="FLItem-4-SLItem-15-SLItem-4"> Scientific Conferences Program </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/scientific-community-initiatives/start-up-network-program" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Start-Up Network Program" menu-type="header" data-value="FLItem-4-SLItem-15-SLItem-5"> Start-Up Network Program </a> </li> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/science/manufacturing" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="Manufacturing" menu-type="header" data-value="FLItem-4-SLItem-16"> Manufacturing </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/manufacturing" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Manufacturing Overview" menu-type="header" data-value="FLItem-4-SLItem-16-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/manufacturing/innovation" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Innovation" menu-type="header" data-value="FLItem-4-SLItem-16-SLItem-2"> Innovation </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/manufacturing/quality" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Quality" menu-type="header" data-value="FLItem-4-SLItem-16-SLItem-3"> Quality </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/science/manufacturing/reliability" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Reliability" menu-type="header" data-value="FLItem-4-SLItem-16-SLItem-4"> Reliability </a> </li> </ul> </li> </ul> </li> <li class="quantum-drop-down-menu__list-item "> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Products" menu-type="header" href="/products" target="" data-value="FLItem-5"> <span class="quantum-drop-down-menu__link-text">PRODUCTS</span> <svg class="quantum-icon quantum-drop-down-menu__link-icon quantum-drop-down-menu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-drop-down-menu__link-icon quantum-drop-down-menu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <ul class="quantum-drop-down-menu__menu"> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/products" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Products Overview" menu-type="header" data-value="FLItem-5-SLItem-17"> Overview </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item" data-value="FLItem-5-SLItem-18"> <a href="/products" gtmclass="gtm-header" ca1="" menu-name="Medical Information" menu-type="header" rel="noopener" class="hide-href"" class="" ><a href="http://www.amgenmedinfo.com" class="quantum-drop-down-menu__menu-link" target="_blank" rel="noopener">Medical Information<i class="fa fa-external-link"></i></a></a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/products/counterfeit-drug-statement" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Counterfeit Drug Statement" menu-type="header" data-value="FLItem-5-SLItem-19"> Counterfeit Drug Statement </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/products/safety-data-sheets" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Safety Data Sheets" menu-type="header" data-value="FLItem-5-SLItem-20"> Safety Data Sheets </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/products/global-patient-safety" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="Global Patient Safety" menu-type="header" data-value="FLItem-5-SLItem-21"> Global Patient Safety </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/products/global-patient-safety" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Global Patient Safety Overview" menu-type="header" data-value="FLItem-5-SLItem-21-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/products/global-patient-safety/who-we-are" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Who We Are" menu-type="header" data-value="FLItem-5-SLItem-21-SLItem-2"> Who We Are </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/products/global-patient-safety/our-commitment" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Our Commitment" menu-type="header" data-value="FLItem-5-SLItem-21-SLItem-3"> Our Commitment </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/products/global-patient-safety/what-we-do" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="What We Do" menu-type="header" data-value="FLItem-5-SLItem-21-SLItem-4"> What We Do </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/products/global-patient-safety/adverse-event-reporting" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Adverse Event and Product Complaint Reporting" menu-type="header" data-value="FLItem-5-SLItem-21-SLItem-5"> Adverse Event and Product Complaint Reporting </a> </li> </ul> </li> </ul> </li> <li class="quantum-drop-down-menu__list-item "> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Responsibility" menu-type="header" href="/responsibility" target="" data-value="FLItem-6"> <span class="quantum-drop-down-menu__link-text">Responsibility</span> <svg class="quantum-icon quantum-drop-down-menu__link-icon quantum-drop-down-menu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-drop-down-menu__link-icon quantum-drop-down-menu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <ul class="quantum-drop-down-menu__menu"> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Responsibility Overview" menu-type="header" data-value="FLItem-6-SLItem-22"> Overview </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility/environmental-social-and-governance-report" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Environmental Social and Governance Report 2023" menu-type="header" data-value="FLItem-6-SLItem-23"> Environmental, Social & Governance Report 2023 </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility/environment-social-and-governance-strategy" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Environment Social and Governance Strategy" menu-type="header" data-value="FLItem-6-SLItem-24"> Environment, Social and Governance Strategy </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility/healthy-people" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="Healthy People" menu-type="header" data-value="FLItem-6-SLItem-25"> Healthy People </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-people" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Healthy People Overview" menu-type="header" data-value="FLItem-6-SLItem-25-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-people/access-to-medicines" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Access to Medicines" menu-type="header" data-value="FLItem-6-SLItem-25-SLItem-2"> Access to Healthcare </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-people/health-equity" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Health Equity" menu-type="header" data-value="FLItem-6-SLItem-25-SLItem-3"> Health Equity </a> </li> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility/healthy-society" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="Healthy Society" menu-type="header" data-value="FLItem-6-SLItem-26"> Healthy Society </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-society" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Healthy Society Overview" menu-type="header" data-value="FLItem-6-SLItem-26-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-society/diversity-and-inclusion" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Diversity Inclusion and Belonging" menu-type="header" rel="noopener" data-value="FLItem-6-SLItem-26-SLItem-2"> Diversity, Inclusion and Belonging </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-society/human-capital-management" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Human Capital Management" menu-type="header" rel="noopener" data-value="FLItem-6-SLItem-26-SLItem-3"> Human Capital Management </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-society/community-investment" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Community Investment and Amgen Foundation" menu-type="header" data-value="FLItem-6-SLItem-26-SLItem-4"> Community Investment and Amgen Foundation </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/partners/suppliers/supplier-diversity" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Supplier Diversity" menu-type="header" data-value="FLItem-6-SLItem-26-SLItem-5"> Supplier Diversity </a> </li> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility/healthy-planet" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="Healthy Planet" menu-type="header" data-value="FLItem-6-SLItem-27"> Healthy Planet </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-planet" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Healthy Planet Overview" menu-type="header" data-value="FLItem-6-SLItem-27-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-planet/environmental-sustainability" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Environmental Sustainability" menu-type="header" data-value="FLItem-6-SLItem-27-SLItem-2"> Environmental Sustainability </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-planet/supplier-sustainability" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Supplier Sustainability" menu-type="header" data-value="FLItem-6-SLItem-27-SLItem-3"> Supplier Sustainability </a> </li> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility/a-healthy-amgen" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="A Healthy Amgen" menu-type="header" data-value="FLItem-6-SLItem-28"> A Healthy Amgen </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/a-healthy-amgen" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="A Healthy Amgen Overview" menu-type="header" data-value="FLItem-6-SLItem-28-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/about/how-we-operate/corporate-governance" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Corporate Governance" menu-type="header" data-value="FLItem-6-SLItem-28-SLItem-2"> Corporate Governance </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/a-healthy-amgen/business-ethics-and-compliance" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Business Ethics and Compliance" menu-type="header" data-value="FLItem-6-SLItem-28-SLItem-3"> Business Ethics and Compliance </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/a-healthy-amgen/ethical-research" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Ethical Research" menu-type="header" data-value="FLItem-6-SLItem-28-SLItem-4"> Ethical Research and Development </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/products/global-patient-safety" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Patient Safety" menu-type="header" data-value="FLItem-6-SLItem-28-SLItem-5"> Patient Safety </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/about/how-we-operate/policies-practices-and-disclosures/business-conduct/quality" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Product Quality" menu-type="header" data-value="FLItem-6-SLItem-28-SLItem-6"> Product Quality </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/a-healthy-amgen/cybersecurity-and-data-privacy" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Cybersecurity and Data Privacy" menu-type="header" data-value="FLItem-6-SLItem-28-SLItem-7"> Cybersecurity and Data Privacy </a> </li> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="Reporting and Metrics" menu-type="header" data-value="FLItem-6-SLItem-29"> Reporting and Metrics </a> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Reporting and Metrics Overview" menu-type="header" data-value="FLItem-6-SLItem-29-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics/cdp" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="CDP" menu-type="header" data-value="FLItem-6-SLItem-29-SLItem-2"> CDP </a> </li> <li class="quantum-drop-down-menu__menu-list-item "> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics/archived-reports" class="quantum-drop-down-menu__menu-link gtm-header sub-menu-item " menu-name="Archived Reports" menu-type="header" data-value="FLItem-6-SLItem-29-SLItem-3"> Archived Reports </a> </li> </ul> </li> </ul> </li> <li class="quantum-drop-down-menu__list-item "> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Stories" menu-type="header" href="/stories" target="" data-value="FLItem-7"> <span class="quantum-drop-down-menu__link-text">Stories</span> <svg class="quantum-icon quantum-drop-down-menu__link-icon quantum-drop-down-menu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-drop-down-menu__link-icon quantum-drop-down-menu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <ul class="quantum-drop-down-menu__menu"> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/stories" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="All Stories" menu-type="header" data-value="FLItem-7-SLItem-30"> All Stories </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/stories/categories/responsibility" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Responsibility" menu-type="header" data-value="FLItem-7-SLItem-31"> Responsibility </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/stories/categories/people-and-culture" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="People and Culture" menu-type="header" data-value="FLItem-7-SLItem-32"> People and Culture </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/stories/categories/science-and-innovation" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Science and Innovation" menu-type="header" data-value="FLItem-7-SLItem-33"> Science and Innovation </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/stories/categories/patients" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Patients" menu-type="header" data-value="FLItem-7-SLItem-34"> Patients </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> <li class="quantum-drop-down-menu__menu-list-item"> <a href="/stories/categories/leadership" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Leadership" menu-type="header" data-value="FLItem-7-SLItem-35"> Leadership </a> <ul class="quantum-drop-down-menu__tertiary"> </ul> </li> </ul> </li> <li class="quantum-drop-down-menu__list-item right-links media"> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Newsroom" menu-type="header" href="/newsroom" target="" data-value="FLItem-8"> <span class="quantum-drop-down-menu__link-text">Newsroom</span> </a> </li> <li class="quantum-drop-down-menu__list-item right-links"> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Partners" menu-type="header" href="/partners" target="" data-value="FLItem-9"> <span class="quantum-drop-down-menu__link-text">Partners</span> </a> </li> <li class="quantum-drop-down-menu__list-item right-links"> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Investors" menu-type="header" rel="noopener" href="http://investors.amgen.com/" target="_blank" data-value="FLItem-10"> <span class="quantum-drop-down-menu__link-text">Investors</span> </a> </li> <li class="quantum-drop-down-menu__list-item right-links"> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Careers" menu-type="header" rel="noopener" href="http://careers.amgen.com/" target="_blank" data-value="FLItem-11"> <span class="quantum-drop-down-menu__link-text">Careers</span> </a> </li> <li class="quantum-drop-down-menu__list-item d-lg-none mobWW"> <a class="quantum-drop-down-menu__link gtm-header" menu-name="Amgen Worldwide" menu-type="header" href="/amgen-worldwide" target="" data-value="FLItem-12"> <span class="quantum-drop-down-menu__link-text">Amgen Worldwide</span> </a> </li> </ul> <ul class="quantum-drop-down-menu__top-nav-list"> <li class="quantum-drop-down-menu__top-nav-list-item "> <span class="quantum-drop-down-menu__top-nav-link-text"> <div class="quantum-quicklinks__column menu-social-links"> <ul class="quantum-list-group quantum-quicklinks__column-list-group quantum-list-group--small"> <li class="quantum-list-group__item socialIcon"> <a class="quantum-list-group__link " href="https://www.linkedin.com/company/amgen" target="_blank" rel="noopener"> <img alt="linkedIn-icon" class="linkedIn-icon d-none d-sm-block lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/d-linkedin-icon.svg" /> <img alt="linkedIn-icon" class="linkedIn-icon d-block d-sm-none lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/m-linkedin-icon.svg" /> </a> </li> <li class="quantum-list-group__item socialIcon"> <a class="quantum-list-group__link" href="http://www.twitter.com/amgen" target="_blank" rel="noopener"> <img alt="twitter-icon" class="twitter-icon d-none d-sm-block lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/d-twitter-icon.svg" /> <img alt="twitter-icon" class="twitter-icon d-block d-sm-none lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/m-twitter-icon.svg" /> </a> </li> <li class="quantum-list-group__item socialIcon"> <a class="quantum-list-group__link" href="https://www.youtube.com/user/Amgen" target="_blank" rel="noopener"> <img alt="youtube-icon" class="youtube-icon d-none d-sm-block lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/d-youtube-icon.svg" /> <img alt="youtube-icon" class="youtube-icon d-block d-sm-none lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/m-youtube-icon.svg" /> </a> </li> <li class="quantum-list-group__item socialIcon"> <a class="quantum-list-group__link" href="https://www.facebook.com/amgenbiotech/" target="_blank" rel="noopener"> <img alt="facebook-icon" class="facebook-icon d-none d-sm-block lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/d-facebook-icon.svg" /> <img alt="facebook-icon" class="facebook-icon d-block d-sm-none lozad" data-src="-/media/Themes/Global/Global/Global/images/migration/Footer/m-facebook-icon.svg" /> </a> </li> <li class="quantum-list-group__item socialIcon"> <a class="quantum-list-group__link" href="https://www.instagram.com/amgenbiotech/" target="_blank" rel="noopener"> 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<svg class="quantum-icon quantum-button__icon"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#"></use> </svg> </button> <button class="quantum-button quantum-button--tertiary quantum-header__icon-button evenity-sub-nav__menu-trigger evenity-sub-nav__menu-trigger--expand-menu quantum-button--large quantum-button--icon-only collapse" type="button"> <svg class="quantum-icon quantum-button__icon"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#"></use> </svg> </button> </div> <ul class="quantum-drop-down-menu__menu"> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/products" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="Our Medicines" menu-type="header" data-value="FLItem-5-SLItem-1"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/sitecore/content/CorporateAffairs/Amgen/amgen-sa/Home/contact-us/medical-questions" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="<a href="http://www.amgenmedinfo.com" class="quantum-drop-down-menu__menu-link" target="_blank" rel="noopener">Medical Information<i class="fa fa-external-link"></i></a>" menu-type="header" data-value="FLItem-5-SLItem-2"> Medical Information </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/products/counterfeit-drug-statement" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="" menu-type="header" data-value="FLItem-5-SLItem-3"> Counterfeit Drug Statement </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/products/safety-data-sheets" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="" menu-type="header" data-value="FLItem-5-SLItem-4"> Safety Data Sheets </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item desktip-menu-right-icon"> <a href="/products/global-patient-safety" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header desktip-menu-right-icon" menu-name="" menu-type="header" data-value="FLItem-5-SLItem-5"> Global Patient Safety </a> </li> </ul> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__list-item "> <a href="/products/global-patient-safety" class="quantum-drop-down-menu__menu-link ">Overview</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/products/global-patient-safety/who-we-are" class="quantum-drop-down-menu__menu-link ">Who We Are</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/products/global-patient-safety/our-commitment" class="quantum-drop-down-menu__menu-link ">Our Commitment</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/products/global-patient-safety/what-we-do" class="quantum-drop-down-menu__menu-link ">What We Do</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/products/global-patient-safety/adverse-event-reporting" class="quantum-drop-down-menu__menu-link ">Adverse Event and Product Complaint Reporting</a> </li> </ul> </div> <div class="quantum-header__mobile-subnavigation"> <div class="quantum-header__mobile-subnavigation-toggle"> <span class="quantum-header__mobile-subnavigation-placeholder"></span> <button class="quantum-button quantum-button--tertiary quantum-header__icon-button evenity-sub-nav__menu-trigger evenity-sub-nav__menu-trigger--expand-menu quantum-button--large quantum-button--icon-only" type="button"> <svg class="quantum-icon quantum-button__icon"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#"></use> </svg> </button> <button class="quantum-button quantum-button--tertiary quantum-header__icon-button evenity-sub-nav__menu-trigger evenity-sub-nav__menu-trigger--expand-menu quantum-button--large quantum-button--icon-only collapse" type="button"> <svg class="quantum-icon quantum-button__icon"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#"></use> </svg> </button> </div> <ul class="quantum-drop-down-menu__menu"> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/responsibility" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="" menu-type="header" data-value="FLItem-6-SLItem-6"> Overview </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/responsibility/environmental-social-and-governance-report" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="" menu-type="header" data-value="FLItem-6-SLItem-7"> Environmental, Social & Governance Report 2023 </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/responsibility/environment-social-and-governance-strategy" class="quantum-drop-down-menu__menu-link gtm-header " menu-name="" menu-type="header" data-value="FLItem-6-SLItem-8"> Environment, Social and Governance Strategy </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item mega-menu-innerlist"> <a href="/responsibility/healthy-people" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header mega-menu-innerlist" menu-name="" menu-type="header" data-value="FLItem-6-SLItem-9"> Healthy People </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item "> <a href="/responsibility/healthy-society" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header " menu-name="" menu-type="header" data-value="FLItem-6-SLItem-10"> Healthy Society </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item desktip-menu-right-icon"> <a href="/responsibility/healthy-planet" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header desktip-menu-right-icon" menu-name="" menu-type="header" data-value="FLItem-6-SLItem-11"> Healthy Planet </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item desktip-menu-right-icon"> <a href="/responsibility/a-healthy-amgen" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header desktip-menu-right-icon" menu-name="" menu-type="header" data-value="FLItem-6-SLItem-12"> A Healthy Amgen </a> </li> <li class="quantum-drop-down-menu__menu-list-item quantum-drop-down-menu__list-item mega-menu-innerlist"> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics" class="quantum-drop-down-menu__menu-link desktop-submenu-right-icon gtm-header mega-menu-innerlist" menu-name="" menu-type="header" data-value="FLItem-6-SLItem-13"> Reporting and Metrics </a> </li> </ul> <ul class="quantum-drop-down-menu__tertiary"> <li class="quantum-drop-down-menu__list-item "> <a href="/responsibility/a-healthy-amgen" class="quantum-drop-down-menu__menu-link ">Overview</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/about/how-we-operate/corporate-governance" class="quantum-drop-down-menu__menu-link ">Corporate Governance</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/responsibility/a-healthy-amgen/business-ethics-and-compliance" class="quantum-drop-down-menu__menu-link ">Business Ethics and Compliance</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/responsibility/a-healthy-amgen/ethical-research" class="quantum-drop-down-menu__menu-link ">Ethical Research and Development</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/products/global-patient-safety" class="quantum-drop-down-menu__menu-link ">Patient Safety</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/about/how-we-operate/policies-practices-and-disclosures/business-conduct/quality" class="quantum-drop-down-menu__menu-link ">Product Quality</a> </li> <li class="quantum-drop-down-menu__list-item "> <a href="/responsibility/a-healthy-amgen/cybersecurity-and-data-privacy" class="quantum-drop-down-menu__menu-link ">Cybersecurity and Data Privacy</a> </li> </ul> </div> </div> <div class="quantum-header mega-menu-container quantum-container--primary " id=""> <div class="quantum-header__inner"> <div class="quantum-header__left"> <a class="quantum-header__logo d-none d-sm-block gtm-header" menu-type="header" menu-name="Amgen logo" href="/"> <img src="-/media/Themes/Global/Global/Global/images/migration/Common/amgen-blue.svg?la=en&hash=2F9332F2F46EA1E1EF9CCF9D40B8C7B8" class="quantum-header__logo" rel="preload" fetchpriority="high" alt="Amgen Logo" /> </a> <a class="quantum-header__logo d-block d-sm-none gtm-header" href="/" menu-type="header" menu-name="Amgen logo"> <img src="-/media/Themes/Global/Global/Global/images/migration/Common/amgen-blue.svg?la=en&hash=2F9332F2F46EA1E1EF9CCF9D40B8C7B8" class="quantum-header__logo" rel="preload" fetchpriority="high" alt="Amgen Logo" /> </a> </div> <div class="quantum-header__right"> <div class="quantum-header__menu"> <nav class="quantum-megamenu"> <ul class="quantum-megamenu__list"> <li class="quantum-megamenu__list-item "> <a href="/about" class="quantum-prevent-nav quantum-megamenu__link gtm-header" ca1="" menu-name="About" menu-type="header"" target="" value="FLItem-1" > <span class="quantum-megamenu__link-text"> About </span> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <div class="quantum-megamenu__menu"> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/about" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="About" menu-type="header"" target="" value="FLItem-1-SLItem-1" >Overview</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/amgen-history" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Amgen History" menu-type="header"" target="" value="FLItem-1-SLItem-2" >Amgen History</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/mission-and-values" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Mission and Values" menu-type="header"" target="" value="FLItem-1-SLItem-3" >Mission and Values</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/leadership" class=" quantum-megamenu__menu-link gtm-header" ca1="" class="hide-href" menu-name="Leadership" menu-type="header"" target="" value="FLItem-1-SLItem-4" >Leadership</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="https://www.amgenfoundation.org/" class=" quantum-megamenu__menu-link gtm-header" ca1="" class="hide-href" menu-name="Leadership" menu-type="header"" target="_blank" value="FLItem-1-SLItem-5" >Amgen Foundation <i class="fa fa-external-link"></i></a> </li> </ul> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/about/awards-and-accolades" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Awards and Accolades" menu-type="header"" target="" value="FLItem-1-SLItem-6" >Awards and Accolades</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/how-we-operate" class="desktip-menu-right-icon quantum-megamenu__menu-link desktop-submenu-right-icon gtm-header" ca1="" menu-name="How We Operate" menu-type="header"" target="" value="FLItem-1-SLItem-7" >How We Operate</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/how-we-operate/corporate-governance" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Corporate Governance" menu-type="header"" target="" value="FLItem-1-SLItem-8" >Corporate Governance</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/a-healthy-amgen/business-ethics-and-compliance" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Business Ethics and Compliance" menu-type="header"" target="" value="FLItem-1-SLItem-9" >Business Ethics and Compliance</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/how-we-operate/policies-practices-and-disclosures" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Policies Practices and Disclosures" menu-type="header"" target="" value="FLItem-1-SLItem-10" >Policies, Practices and Disclosures</a> </li> </ul> </div> </li> <li class="quantum-megamenu__list-item "> <a href="/science" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Science" menu-type="header"" target="" value="FLItem-2" > <span class="quantum-megamenu__link-text"> Science </span> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <div class="quantum-megamenu__menu"> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/science" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Science" menu-type="header"" target="" value="FLItem-2-SLItem-11" >Overview</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/research-and-development-strategy" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Research and Development Strategy" menu-type="header"" target="" value="FLItem-2-SLItem-12" >Research and Development Strategy</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/research-and-development-strategy/human-data" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Human Data" menu-type="header"" target="" value="FLItem-2-SLItem-13" >Human Data</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/research-and-development-strategy/ai-and-data-science" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="AI and Data Science" menu-type="header"" target="" value="FLItem-2-SLItem-14" >AI & Data Science</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/research-and-development-strategy/multispecifics-and-other-modalities" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Multispecifics and Other Modalities" menu-type="header"" target="" value="FLItem-2-SLItem-15" >Multispecifics & Other Modalities</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/research-and-development-strategy/clinical-trial-innovation" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Clinical Trial Innovation" menu-type="header"" target="" value="FLItem-2-SLItem-16" >Clinical Trial Innovation</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="http://www.amgenpipeline.com/" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Pipeline" menu-type="header" rel="noopener"" target="_blank" value="FLItem-2-SLItem-17" >Pipeline <i class="fa fa-external-link"></i></a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/podcasts" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Amgen Science Podcasts" menu-type="header"" target="" value="FLItem-2-SLItem-18" >Amgen Science Podcasts</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/scientific-advisory-boards" class=" quantum-megamenu__menu-link gtm-header" ca1="" class="hide-href" menu-name="Scientific Advisory Boards" menu-type="header"" target="" value="FLItem-2-SLItem-19" >Scientific Advisory Boards</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/biosimilars" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Biosimilars" menu-type="header" rel="noopener"" target="" value="FLItem-2-SLItem-20" >Biosimilars</a> </li> </ul> <ul class="quantum-megamenu__menu-column desktip-menu-right-icon"> <li class="quantum-megamenu__menu-list-item"> <a href="/science/clinical-trials" class="desktip-menu-right-icon quantum-megamenu__menu-link desktop-submenu-right-icon gtm-header" ca1="" menu-name="Clinical Trials" menu-type="header"" target="" value="FLItem-2-SLItem-21" >Clinical Trials</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/clinical-trials/about-clinical-trials" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="About Clinical Trials" menu-type="header"" target="" value="FLItem-2-SLItem-22" >About Clinical Trials</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="https://www.amgentrials.com" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Amgen Clinical Trials" menu-type="header" rel="noopener"" target="" value="FLItem-2-SLItem-23" >Amgen Clinical Trials <i class="fa fa-external-link"></i></a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/clinical-trials/clinical-trial-diversity" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Clinical Trial Diversity" menu-type="header"" target="" value="FLItem-2-SLItem-24" >Clinical Trial Diversity and Representation</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/clinical-trials/information-for-healthcare-professionals" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Information for Healthcare Professionals" menu-type="header"" target="" value="FLItem-2-SLItem-25" >Information for Healthcare Professionals</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/clinical-trials/clinical-data-transparency-practices" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Clinical Trial Transparency Data Sharing and Disclosures Practices" menu-type="header"" target="" value="FLItem-2-SLItem-26" >Clinical Trial Transparency, Data Sharing and Disclosure Practices</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/clinical-trials/clinical-out-of-hours-support-program" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Clinical Out of Hours Support Program" menu-type="header"" target="" value="FLItem-2-SLItem-27" >Clinical Out-of-Hours Support Program</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="http://www.amgeniss.com" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Investigator Sponsored Activities" menu-type="header" rel="noopener"" target="" value="FLItem-2-SLItem-28" >Investigator Sponsored Studies <i class="fa fa-external-link"></i></a> </li> </ul> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/science/scientific-community-initiatives" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Scientific Community Initiatives" menu-type="header"" target="" value="FLItem-2-SLItem-29" >Scientific Community Initiatives</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/scientific-community-initiatives/educational-outreach-program" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Educational Outreach Program" menu-type="header"" target="" value="FLItem-2-SLItem-30" >Educational Outreach Program </a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/scientific-community-initiatives/postdoctoral-fellows" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Postdoctoral Fellows Program" menu-type="header"" target="" value="FLItem-2-SLItem-31" >Postdoctoral Fellows Program</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/scientific-community-initiatives/scientific-conferences-program" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Scientific Conferences Program" menu-type="header"" target="" value="FLItem-2-SLItem-32" >Scientific Conferences Program</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/scientific-community-initiatives/start-up-network-program" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Start-Up Network Program" menu-type="header"" target="" value="FLItem-2-SLItem-33" >Start-Up Network Program</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/manufacturing" class=" quantum-megamenu__menu-link desktop-submenu-right-icon gtm-header" ca1="" menu-name="Manufacturing" menu-type="header"" target="" value="FLItem-2-SLItem-34" >Manufacturing</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/manufacturing/innovation" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Innovation" menu-type="header"" target="" value="FLItem-2-SLItem-35" >Innovation</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/manufacturing/quality" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Quality" menu-type="header"" target="" value="FLItem-2-SLItem-36" >Quality</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/science/manufacturing/reliability" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Reliability" menu-type="header"" target="" value="FLItem-2-SLItem-37" >Reliability</a> </li> </ul> </div> </li> <li class="quantum-megamenu__list-item "> <a href="/products" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Products" menu-type="header"" target="" value="FLItem-3" > <span class="quantum-megamenu__link-text"> PRODUCTS </span> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <div class="quantum-megamenu__menu"> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/products" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Science" menu-type="header"" target="" value="FLItem-3-SLItem-38" >Overview</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="http://www.amgenmedinfo.com/" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Medical Information" menu-type="header" rel="noopener"" target="_blank" value="FLItem-3-SLItem-39" >Medical Information <i class="fa fa-external-link"></i></a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/products/counterfeit-drug-statement" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Counterfeit Drug Statement" menu-type="header"" target="" value="FLItem-3-SLItem-40" >Counterfeit Drug Statement</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/products/safety-data-sheets" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Safety Data Sheets" menu-type="header"" target="" value="FLItem-3-SLItem-41" >Safety Data Sheets</a> </li> </ul> <ul class="quantum-megamenu__menu-column desktip-menu-right-icon"> <li class="quantum-megamenu__menu-list-item"> <a href="/products/global-patient-safety" class="desktip-menu-right-icon quantum-megamenu__menu-link desktop-submenu-right-icon gtm-header" ca1="" menu-name="Global Patrient Safety" menu-type="header"" target="" value="FLItem-3-SLItem-42" >Global Patient Safety</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/products/global-patient-safety/who-we-are" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Who We Are" menu-type="header"" target="" value="FLItem-3-SLItem-43" >Who We Are</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/products/global-patient-safety/our-commitment" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Our Commitment" menu-type="header"" target="" value="FLItem-3-SLItem-44" >Our Commitment</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/products/global-patient-safety/what-we-do" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="What We Do" menu-type="header"" target="" value="FLItem-3-SLItem-45" >What We Do</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/products/global-patient-safety/adverse-event-reporting" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Adverse Event and Product Complaint Reporting" menu-type="header"" target="" value="FLItem-3-SLItem-46" >Adverse Event and Product Complaint Reporting</a> </li> </ul> </div> </li> <li class="quantum-megamenu__list-item "> <a href="/responsibility" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Responsibility" menu-type="header"" target="" value="FLItem-4" > <span class="quantum-megamenu__link-text"> Responsibility </span> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <div class="quantum-megamenu__menu"> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Responsibility" menu-type="header"" target="" value="FLItem-4-SLItem-47" >Overview</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/environmental-social-and-governance-report" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Environmental Social and Governance Report 2023" menu-type="header"" target="" value="FLItem-4-SLItem-48" >Environmental, Social & Governance Report 2023</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/environment-social-and-governance-strategy" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Environment Social and Governance Strategy" menu-type="header"" target="" value="FLItem-4-SLItem-49" >Environment, Social and Governance Strategy</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-people" class="mega-menu-innerlist quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Healthy People" menu-type="header"" target="" value="FLItem-4-SLItem-50" >Healthy People</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-people/access-to-medicines" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Access to Medicines" menu-type="header"" target="" value="FLItem-4-SLItem-51" >Access to Healthcare</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-people/health-equity" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Health Equity" menu-type="header"" target="" value="FLItem-4-SLItem-52" >Health Equity</a> </li> </ul> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-society" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Healthy Society" menu-type="header"" target="" value="FLItem-4-SLItem-53" >Healthy Society</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-society/community-investment" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Community Investment and Amgen Foundation" menu-type="header"" target="" value="FLItem-4-SLItem-54" >Amgen Foundation and Community Investment</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-society/diversity-and-inclusion" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Diversity Inclusion and Belonging" menu-type="header" rel="noopener"" target="" value="FLItem-4-SLItem-55" >Diversity, Inclusion and Belonging</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-society/human-capital-management" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Human Capital Management" menu-type="header" rel="noopener"" target="" value="FLItem-4-SLItem-56" >Human Capital Management</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/partners/suppliers/supplier-diversity" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Supplier Diversity" menu-type="header"" target="" value="FLItem-4-SLItem-57" >Supplier Diversity</a> </li> </ul> <ul class="quantum-megamenu__menu-column desktip-menu-right-icon"> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-planet" class="desktip-menu-right-icon quantum-megamenu__menu-link desktop-submenu-right-icon gtm-header" ca1="" menu-name="HealthyPlanet" menu-type="header"" target="" value="FLItem-4-SLItem-58" >Healthy Planet</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-planet/environmental-sustainability" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Environmental Sustainability" menu-type="header"" target="" value="FLItem-4-SLItem-59" >Environmental Sustainability</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-planet/supplier-sustainability" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Supplier Sustainability" menu-type="header"" target="" value="FLItem-4-SLItem-60" >Supplier Sustainability</a> </li> </ul> <ul class="quantum-megamenu__menu-column desktip-menu-right-icon"> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/a-healthy-amgen" class="desktip-menu-right-icon quantum-megamenu__menu-link desktop-submenu-right-icon gtm-header" ca1="" menu-name="A Healthy Amgen" menu-type="header"" target="" value="FLItem-4-SLItem-61" >A Healthy Amgen</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/how-we-operate/corporate-governance" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Corporate Governance" menu-type="header"" target="" value="FLItem-4-SLItem-62" >Corporate Governance</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/a-healthy-amgen/business-ethics-and-compliance" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Business Ethics and Compliance" menu-type="header"" target="" value="FLItem-4-SLItem-63" >Business Ethics and Compliance</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/a-healthy-amgen/ethical-research" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Ethical Research" menu-type="header"" target="" value="FLItem-4-SLItem-64" >Ethical Research and Development</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/products/global-patient-safety" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Patient Safety" menu-type="header"" target="" value="FLItem-4-SLItem-65" >Patient Safety</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/about/how-we-operate/policies-practices-and-disclosures/business-conduct/quality" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Product Quality" menu-type="header"" target="" value="FLItem-4-SLItem-66" >Product Quality</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/a-healthy-amgen/cybersecurity-and-data-privacy" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Cybersecurity and Data Privacy" menu-type="header"" target="" value="FLItem-4-SLItem-67" >Cybersecurity and Data Privacy</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics" class="mega-menu-innerlist quantum-megamenu__menu-link desktop-submenu-right-icon gtm-header" ca1="" menu-name="Reporting and Metrics" menu-type="header"" target="" value="FLItem-4-SLItem-68" >Reporting and Metrics</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics/cdp" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="CDP" menu-type="header"" target="" value="FLItem-4-SLItem-69" >CDP</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/responsibility/healthy-planet/environmental-sustainability/reporting-and-metrics/archived-reports" class=" quantum-megamenu__menu-link gtm-header sub-menu-item" ca1="" menu-name="Archived Reports" menu-type="header"" target="" value="FLItem-4-SLItem-70" >Archived Reports</a> </li> </ul> </div> </li> <li class="quantum-megamenu__list-item "> <a href="/stories" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Stories" menu-type="header"" target="" value="FLItem-5" > <span class="quantum-megamenu__link-text"> Stories </span> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--expand-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-right-regular"></use> </svg> <svg class="quantum-icon quantum-megamenu__link-icon quantum-megamenu__link-icon--collapse-dropdown"> <use xlink:href="-/media/Themes/Global/Global/Global/images/migration/Common/Icon/amgen-com.svg#angle-left-regular"></use> </svg> </a> <div class="quantum-megamenu__menu"> <ul class="quantum-megamenu__menu-column "> <li class="quantum-megamenu__menu-list-item"> <a href="/stories" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="All Stories" menu-type="header"" target="" value="FLItem-5-SLItem-71" >All Stories</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/stories/categories/responsibility" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Responsibility" menu-type="header"" target="" value="FLItem-5-SLItem-72" >Responsibility</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/stories/categories/people-and-culture" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="People and Culture" menu-type="header"" target="" value="FLItem-5-SLItem-73" >People and Culture</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/stories/categories/science-and-innovation" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Science and Innovation" menu-type="header"" target="" value="FLItem-5-SLItem-74" >Science and Innovation</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/stories/categories/patients" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Patients" menu-type="header"" target="" value="FLItem-5-SLItem-75" >Patients</a> </li> <li class="quantum-megamenu__menu-list-item"> <a href="/stories/categories/leadership" class=" quantum-megamenu__menu-link gtm-header" ca1="" menu-name="Leadership" menu-type="header"" target="" value="FLItem-5-SLItem-76" >Leadership</a> </li> </ul> </div> </li> <li class="quantum-megamenu__list-item right-links media"> <a href="/newsroom" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Newsroom" menu-type="header"" target="" value="FLItem-6" > <span class="quantum-megamenu__link-text"> Newsroom </span> </a> </li> <li class="quantum-megamenu__list-item right-links"> <a href="/partners" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Partners" menu-type="header"" target="" value="FLItem-7" > <span class="quantum-megamenu__link-text"> Partners </span> </a> </li> <li class="quantum-megamenu__list-item right-links"> <a href="http://investors.amgen.com/" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Investors" menu-type="header" rel="noopener"" target="_blank" value="FLItem-8" > <span class="quantum-megamenu__link-text"> Investors </span> </a> </li> <li class="quantum-megamenu__list-item right-links"> <a href="http://careers.amgen.com/" class=" quantum-megamenu__link gtm-header" ca1="" menu-name="Careers" menu-type="header" rel="noopener"" target="_blank" value="FLItem-9" > <span class="quantum-megamenu__link-text"> Careers </span> </a> </li> <li class="quantum-megamenu__list-item right-links-web"> <a 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</li> <li class="breadcrumb-item "> <div class="navigation-title field-navigationtitle"><a title="Global Patient Safety" href="/products/global-patient-safety">Global Patient Safety</a></div> <span class="separator">></span> </li> <li class="breadcrumb-item last"> <div class="navigation-title field-navigationtitle"><a title="What We Do" href="/products/global-patient-safety/what-we-do">What We Do</a></div> <span class="separator">></span> </li> </ol> </nav> </div> </div> <div class="component rich-text"><div class="field-banner-title"><div class="banner-content"> <h2>Global Patient Safety</h2> </div></div></div></div></div></div></div> </div> </div> <div class="component container main-content-container"> <div class="component-content" > <div class="row component column-splitter"> <div class="col-sm-12 col-md-8 col-lg-9 col-xl-9 left-container"> <div class="component rich-text white-content"> <div class="component-content"> <h1>What We Do</h1> <p>Pharmacovigilance is a comprehensive set of activities focused on the detection, assessment, understanding and prevention of adverse effects or other product-related problems. Amgen鈥檚 rigorous pharmacovigilance program is executed by the Global Patient Safety Team over the lifecycle of our products.</p> <h2>Safety Data Collection</h2> <p>Amgen collects, reviews, and evaluates adverse events, product complaints, and other safety findings experienced by patients, either as clinical trial participants who receive our investigational drugs or by patients taking our approved products. This information helps us better understand, assess, and communicate the safety profile of Amgen products.</p> <p>Amgen collects and analyzes safety data throughout a product鈥檚 lifecycle. Adverse events for our products are rigorously evaluated during the development process and clinical trials. It is important to continue to collect adverse events and other safety information associated with the use of our products after the product has been approved for use on the market, as more patients are using them. Through data analysis/assessment of these events, and combined with the pre-approval information, Amgen can support the safety management of these products. This information comes through various channels, including additional studies, reports by patients and health care professionals, registries, scientific literature, medical literature, health authority databases, and other external database reviews. We also monitor Amgen-sponsored social media for adverse events, product complaints, and other safety findings. Individual adverse event reports are added to our safety database. If a safety risk is identified, our safety professionals determine how best to prevent, minimize, or mitigate those risks, and accurately communicate those risks to patients, healthcare professionals, and regulatory agencies in a timely manner. Amgen routinely communicates benefit-risk assessments of our products to regulatory agencies by submitting aggregate periodic reports.</p> <p><strong>Learn more:</strong> <a href="/products/global-patient-safety/adverse-event-reporting">Adverse Event and Product Complaint Reporting</a></p> <h2>Safety Governance Framework for Risk Assessment and Evaluation</h2> <p>Amgen鈥檚 safety governance framework is composed of cross-functional governance teams, which bring together individuals with pharmacovigilance, medical, regulatory, quality, and other relevant expertise. Leveraging external expertise when needed, the teams analyze potential safety signals and are responsible for characterizing the safety profile for all products in development and once they are approved.</p> <p>Amgen continuously monitors safety information from different sources to identify safety signals that could potentially suggest new adverse events might be linked to or associated with the use of our products. Risk evaluation or signal detection can take the form of qualitative review of individual cases and/or use of quantitative methods to assist with the review of aggregate data. Appropriate statistical methods and data mining techniques are applied to databases with a large volume of safety data to better detect signals in a timely manner. In addition, product quality monitoring, in the context of adverse events, is also employed to detect safety signals related to the complex manufacturing processes of our biological medicines.</p> <p>Signal detection activities for an Amgen product initiate as soon as the first subject begins to receive an investigational product in a clinical trial and continues throughout the product lifecycle. The strategy of signal detection for each Amgen product is individually tailored depending on its stage of the product lifecycle and safety profile.</p> <p>Signals identified through review of safety data undergo further assessment and are evaluated to determine whether new safety information constitutes a risk to patients.</p> <h2>Product Risk Management</h2> <p>Amgen conducts ongoing benefit-risk assessments of our products as new benefit or risk information related to the product becomes available throughout the product lifecycle. Amgen has in-place a structured risk management planning process to establish appropriate and necessary actions needed to communicate and minimize the risks of a product both during clinical trials and when the product is on the market. Our process is designed to engage the right expertise in the benefit-risk assessment and the development of any risk minimization activities. Through the implementation of risk minimization activities, some of the risks associated with the use of a product may be mitigated or managed in patients. Amgen routinely communicates benefit-risk assessments of our products to regulatory agencies by submitting aggregate periodic reports.</p> <h2>Product Risk Communication</h2> <p>Amgen is committed to timely, appropriate, and transparent communication to patients, healthcare professionals, and regulatory agencies of risks related to our products. For developmental products, the risks are shared with investigators through the investigator brochure. Subjects participating in our trials receive safety information during the informed consent process and through discussions with study investigators. For our marketed products, prescribing physicians and other healthcare professionals are informed through product labeling; they may use this information to counsel patients on the benefits and risks. There is also communication directly to patients through documents that use patient friendly language. Regulatory authorities have the final decision regarding the content and language included in the prescribing information and as a result, labeling documents may vary across countries or regions where the product is approved for commercial use. We also communicate any new clinically significant safety information through direct letters to investigators and/or healthcare providers, when appropriate.</p> <h2>Regulatory Reporting</h2> <p>During the clinical development of a product, Amgen partners with regulatory agencies around the world to evaluate the safety and efficacy of our products. Our marketing applications for product approval include comprehensive safety and efficacy data. Following approval, Amgen continues to inform health authorities on the safety of our products through expedited individual case safety reports, periodic aggregated safety reports, clinical study reports, and other relevant communication on safety issues consistent with applicable regulations. On a regular basis, Safety teams monitor health authority regulations around the world and update processes, as needed, to ensure compliance.</p> </div> </div> </div> <div class="col-sm-12 col-md-4 col-lg-3 col-xl-3 right-nav"> <div class="component navigation navigation-title"> <div class="component-content"> <nav> <ul class="clearfix"> <li class=" level0 submenu item0 odd first last active rel-level1"> <div class="navigation-title field-navigationtitle"><a title="Global Patient Safety" href="/products/global-patient-safety">Global Patient Safety</a></div><ul class="clearfix"> <li class=" level1 item0 odd first rel-level2"> <div class="navigation-title field-navigationtitle"><a title="Who We Are" href="/products/global-patient-safety/who-we-are">Who We Are</a></div> </li> <li class=" level1 item1 even rel-level2"> <div class="navigation-title field-navigationtitle"><a title="Our Commitment" href="/products/global-patient-safety/our-commitment">Our Commitment</a></div> </li> <li 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