{"id":3338,"date":"2021-12-17T12:50:50","date_gmt":"2021-12-17T12:50:50","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=regulator-sessions&p=3338"},"modified":"2022-04-04T17:52:10","modified_gmt":"2022-04-04T17:52:10","slug":"webinar-series-on-utilization-of-voluntary-consensus-standards","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/webinar-series-on-utilization-of-voluntary-consensus-standards\/","title":{"rendered":"Webinar Series on Utilization of Voluntary Consensus Standards"},"content":{"rendered":"\n

The Medical Device Regulatory Convergence Project<\/a> co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence<\/a> in the Medical Technology Sector collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series on the Utilization of Voluntary Consensus Standards.<\/p>\n\n\n\n

Session I. 7 December 2021<\/strong><\/h2>\n\n\n\n

Objective<\/strong>: Provide USFDA\u2019s experience in developing and applying consensus standards while making regulatory decisions that promote safety and effectiveness of medical devices.<\/p>\n\n\n\n

Agenda<\/h2>\n\n\n\n
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Recording<\/h2>\n\n\n\n
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Presentation<\/h2>\n\n\n\n
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Session II. 3 March 2022<\/strong><\/h2>\n\n\n\n

Objective<\/strong>: Provide the perspectives of PAHO\/WHO, WTO and Standards Developing Organization (SDOs) on how international voluntary consensus standards for medical technologies are developed, maintained, and used by regulators and industry to operationalize regulatory reliance, regulatory convergence and to facilitate the manufacturing and approval of quality, safe, secure, interoperable, effective, and accessible medical devices for health systems and patients in the Americas.<\/p>\n\n\n\n

Agenda<\/h2>\n\n\n\n
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Recording<\/h2>\n\n\n\n
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Presentations<\/h2>\n\n\n\n

Part 1. Use of International Standards for Medical Technologies as Key Operationalization of Regulatory Reliance, Regulatory Convergence and Legal Compliance<\/strong><\/h3>\n\n\n\n

Health References for Medical Device National Regulatory Authorities – Alexandre Lemgruber, PAHO<\/h4>\n\n\n\n
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Legal Obligations applicable to medical device National Regulatory Authorities – Technical Barriers to Trade Agreement – Devin McDaniels, WTO<\/h4>\n\n\n\n
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Legal Obligations applicable to medical device National Regulatory Authorities – Renata Amaral, IACRC<\/h4>\n\n\n\n
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International Standards – Development, Adoption and Use by Stakeholders including Regulatory Authorities – Kory Eguino, COPANT<\/h4>\n\n\n\n
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Part 2. Panel Discussion: Overview of MedTech Standard Development Organizations Work<\/strong><\/h3>\n\n\n\n

ISO \/ TC210 – Peter Linders, Philips<\/h4>\n\n\n\n
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Spanish Translations Task Force ISO \/ TC210 – Veronica Viscovich, IRAM. Coming soon!<\/h4>\n\n\n\n
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IEC \/ TC 62 \u2013 Brodie Pedersen<\/h4>\n\n\n\n
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IMDRF and standards \u2013 Kenneth Cavanaugh, USFDA<\/h4>\n\n\n\n
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AAMI \u2013 Hae Choe<\/h4>\n\n\n\n
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CLSI & ISO TC212 \u2013 Patrick McGinn<\/h4>\n\n\n\n
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MITA \u2013 Carolyn Hull<\/h4>\n\n\n\n
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ASTM International \u2013 Craig Updyke<\/h4>\n\n\n\n
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Session III. 10 March 2022<\/strong><\/h2>\n\n\n\n

Objective<\/strong>: Provide the perspectives of National Standards Bodies (NSBs) on how international voluntary consensus standards for medical technologies are developed, maintained and used by regulators and industry to operationalize regulatory reliance, regulatory convergence and to facilitate the manufacturing and approval of quality, safe, secure, interoperable, effective and accessible medical devices for health systems and patients in the Americas.<\/p>\n\n\n\n

Agenda<\/h2>\n\n\n\n
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Recording<\/h2>\n\n\n\n
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Presentations<\/h2>\n\n\n\n

Brazil<\/strong><\/h3>\n\n\n\n

ABNT, Jorge Cajazeira, Assesor de \u00c1rea Internacional<\/h4>\n\n\n\n
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CB-036, Humberto Tiburcio, SBAC<\/h4>\n\n\n\n
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Colombia<\/strong><\/h3>\n\n\n\n

ICONTEC \u2013 Andr\u00e9s Hern\u00e1ndez<\/h4>\n\n\n\n
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Mexico<\/strong><\/h3>\n\n\n\n

DGN \u2013 Emeterio Mosso<\/h4>\n\n\n\n
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ANCE \u2013 Luis Iv\u00e1n Hern\u00e1ndez Becerril<\/h4>\n\n\n\n
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Peru<\/strong><\/h3>\n\n\n\n

INACAL \u2013 Soraya Lastra<\/h4>\n\n\n\n
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Session IV. 17 March 2022<\/strong><\/h2>\n\n\n\n

Objective<\/strong>: Provide the perspectives of government authorities, industry and the conformity assessment sector and industry on how conformity assessment is a global tool used by regulators and industry to demonstrate compliance with requirements \u2013 facilitating the manufacture and approval of quality, safe, secure, interoperable, effective and accessible medical devices for health systems and patients in the Americas.<\/p>\n\n\n\n

Agenda<\/h2>\n\n\n\n
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Recording<\/h2>\n\n\n\n
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Portuguese<\/a><\/div>\n<\/div>\n\n\n\n

Presentations<\/h2>\n\n\n\n

Part I<\/strong><\/h3>\n\n\n\n

Conformity Assessment as Essential Resource for Medical Device Regulatory Authorities, Industry and Regulatory Convergence<\/strong><\/h4>\n\n\n\n

Overview of Conformity Assessment and Government utilization of CA: Gordon Gillerman, NIST<\/h4>\n\n\n\n
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MedTech Industry Experience with CA: Elisabeth George, Philips<\/h4>\n\n\n\n
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Conformity Assessment Sector Perspective: Martin Michelot, TIC Council<\/h4>\n\n\n\n
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IECEE CB Scheme: Steven Margis, UL<\/h4>\n\n\n\n
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Part II<\/strong><\/h3>\n\n\n\n

Panel discussion: Utilization of International Standards and Conformity Assessment by Medical Device National Regulatory Authorities<\/strong><\/h4>\n\n\n\n

Colombia<\/strong><\/h4>\n\n\n\n

Ministry of Health, Soleiny Mar\u00edn Cort\u00e9s<\/h4>\n\n\n\n
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INVIMA \u2013 Eleonora Celis Ca\u00f1as<\/h4>\n\n\n\n
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Mexico<\/strong><\/h4>\n\n\n\n

COFEPRIS \u2013 Llaneth Bola\u00f1os Valerio<\/h4>\n\n\n\n
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FEUM \u2013 Rafael Hern\u00e1ndez<\/h4>\n\n\n\n
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English<\/a><\/div>\n\n\n\n
Spanish<\/a><\/div>\n\n\n\n
Portuguese<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-3338","regulator-sessions","type-regulator-sessions","status-publish","hentry","description-off"],"acf":[],"yoast_head":"\nWebinar Series on Utilization of Voluntary Consensus Standards - 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\/regulator-sessions\/webinar-series-on-utilization-of-voluntary-consensus-standards\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Webinar Series on Utilization of Voluntary Consensus Standards - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"The Medical Device Regulatory Convergence Project co-lead by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector collaborated with the United States Food and Drug Administration (FDA) to organize a webinar series on the Utilization of Voluntary Consensus Standards. 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