{"id":4773,"date":"2023-11-30T16:41:43","date_gmt":"2023-11-30T16:41:43","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=policy-training&#038;p=4773"},"modified":"2025-02-06T12:10:51","modified_gmt":"2025-02-06T12:10:51","slug":"mdrc-inter-american-coalition-for-regulatory-convergence-in-the-medical-technology-sector-external-stakeholders-meeting","status":"publish","type":"policy-training","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/mdrc-inter-american-coalition-for-regulatory-convergence-in-the-medical-technology-sector-external-stakeholders-meeting\/","title":{"rendered":"MDRC &#8211; Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector External Stakeholders Meeting"},"content":{"rendered":"\n<p>The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector held the \u201cExternal Stakeholders Virtual Meeting\u201d on October 10th in San Salvador, El Salvador.<\/p>\n\n\n\n<p class=\"mb-3\">Topics covered during the event included Emergency Use Authorizations, Electronic CFG\/FSC, Electronic Regulatory Tools, Reliance and Regulators&#8217; Databases.<\/p>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Agenda (English only)<\/h2>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/11\/External-Stakeholders-Session-10Oct23-V15.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Recordings<\/h2>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/youtu.be\/aRH1x6YiKoM?si=mswZ7XNZGAICJF6Y\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n\n\n\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/youtu.be\/YQyOLk5jKHY?si=sFNTcRzsMkljaeWt\" target=\"_blank\" rel=\"noreferrer noopener\">Portuguese<\/a><\/div>\n\n\n\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\">Spanish &#8211; Coming soon!<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Presentations<\/h2>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Medical Device Regulatory Convergence, COVID 19 (MDRC). The Journey &#8211; Sandra Ligia Gonz\u00e1lez, MDRC<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/11\/MDRC-IACRC-Engagement-w-Ext-Stakeholders.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Spanish<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Conversation on Emergency Use Authorization (EUA). Where we were and where we are after COVID-19 Pandemic?<\/strong>:<\/h5>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">Emergency Use Authorization (EUA) Where we were and where we are after COVID-19 Pandemic &#8211; Marcella Abreu, ANVISA. Coming soon!<\/h6>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">Where we were and where we are now after COVID Pandemic. The Brazilian Perspective &#8211; Carlos Go\u016bvea, CBDL.<\/h6>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/11\/Where-we-were-and-where-we-are-now-after-COVID-Pandemic.-The-Brazilian-Perspective-.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Electronic CFG\/FSC &#8211; A proactive approach to a new reality. Part I<\/strong>:<\/h5>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">eCFG\/eFSC benefits and risks for a regulator \u2013 Ethny Obas, US FDA CDRH.<\/h6>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2024\/03\/CDRH-e-Certificates-Transition-posted.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">Position paper on eCFG\/eFSC \u2013 Marina Carvalho, IACRC.<\/h6>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/11\/Position-Paper-eCFG-FSC.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Electronic Regulatory Tools \u2013 A proactive approach to a new reality. Part II. Reliance &#8211; Leveraging regulators\u2019 data bases<\/strong>:<\/h5>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">Electronic Regulatory Tools &#8211; a proactive approach to a new reality. Digital Systems of INPM. (Spanish) &#8211; Carolina Magnatti, ANMAT<\/h6>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2023\/11\/Herramientas-regulatorias-electronicas-Un-enfoque-proactivo-para-una-nueva-realidad.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Spanish<\/a><\/div>\n<\/div>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">(Electronic) Regulatory Tools Part II. Reliance &#8211; Leveraging regulator&#8217;s database &#8211; H\u00e9lio Bonfim de Macedo Filho, ANVISA. Coming soon!<\/h6>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">Medical Devices Databases &#8211; Vesa Vuniqi, US FDA. Coming soon!<\/h6>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Turning Reliance into a Reality:<\/strong><\/h5>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">Turning Reliance into a Reality. The Brazilian proposal &#8211; Augusto Geyer, ANVISA. Coming soon!<\/h6>\n\n\n\n<h6 class=\"wp-block-heading mb-1\" style=\"font-size:16px\">Regulatory Reliance &#8211; A Reality. Singapore Experience &#8211; Rama Sethuraman, HSA. Coming soon!<\/h6>\n","protected":false},"parent":0,"menu_order":0,"template":"","event_category":[],"class_list":["post-4773","policy-training","type-policy-training","status-publish","hentry","description-off"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDRC - Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector External Stakeholders Meeting - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/policy-training\/mdrc-inter-american-coalition-for-regulatory-convergence-in-the-medical-technology-sector-external-stakeholders-meeting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDRC - Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector External Stakeholders Meeting - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"The Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector held the \u201cExternal Stakeholders Virtual Meeting\u201d on October 10th in San Salvador, El Salvador. 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Agenda (English only) Recordings Presentations Medical Device Regulatory Convergence, COVID 19 (MDRC).&hellip;","_links":{"self":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/policy-training\/4773","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/policy-training"}],"about":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/types\/policy-training"}],"wp:attachment":[{"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/media?parent=4773"}],"wp:term":[{"taxonomy":"event_category","embeddable":true,"href":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-json\/wp\/v2\/event_category?post=4773"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}