{"id":55613,"date":"2023-04-07T11:03:03","date_gmt":"2023-04-07T09:03:03","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/2-day-medical-device-regulatory-requirements-and-adverse-event-reporting-training-course-may-25-26-2023-researchandmarkets-com\/"},"modified":"2023-04-07T11:03:03","modified_gmt":"2023-04-07T09:03:03","slug":"2-day-medical-device-regulatory-requirements-and-adverse-event-reporting-training-course-may-25-26-2023-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/2-day-medical-device-regulatory-requirements-and-adverse-event-reporting-training-course-may-25-26-2023-researchandmarkets-com\/","title":{"rendered":"2 Day Medical Device Regulatory Requirements and Adverse Event Reporting Training Course (May 25-26, 2023) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5744426\/medical-device-studies-regulatory-requirements?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=3l9rdn&amp;utm_campaign=1835901+-+2+Day+Medical+Device+Regulatory+Requirements+and+Adverse+Event+Reporting+Training+Course+(May+25-26%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230407005052\/en\/1758775\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230407005052\/en\/1758775\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies.<\/p>\n<p>\nThe course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives.<\/p>\n<p>\nIt will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period.<\/p>\n<p>\nIt also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.<\/p>\n<p>\n<strong>Who Should Attend:<\/strong><\/p>\n<ul>\n<li>\nRegulatory affairs specialists<\/li>\n<li>\nQuality assurance specialists<\/li>\n<li>\nClinical research associates<\/li>\n<li>\nJunior clinical research associates<\/li>\n<li>\nProfessionals involved in reporting adverse events during pre- and post-market clinical studies<\/li>\n<\/ul>\n<p>\n<strong>Agenda:<\/strong><\/p>\n<p>\n<strong>The Medical Device Studies: Regulatory Requirements and Adverse Event Reporting course will cover:<\/strong><\/p>\n<p>\n<strong>Clinical evaluation &#8211; An Overview<\/strong><\/p>\n<ul>\n<li>\nWhat is a clinical evaluation?<\/li>\n<li>\nHow do you conduct a clinical evaluation?<\/li>\n<li>\nThe regulatory requirements pertaining to clinical evaluation<\/li>\n<\/ul>\n<p>\n<strong>Clinical investigations &#8211; An Overview<\/strong><\/p>\n<ul>\n<li>\nWhat is a clinical investigation?<\/li>\n<li>\nWhen are clinical investigations needed?<\/li>\n<li>\nThe regulatory requirements<\/li>\n<\/ul>\n<p>\n<strong>PMS and PMCF<\/strong><\/p>\n<ul>\n<li>\nWhat is PMS?<\/li>\n<li>\nWhat is PMCF?<\/li>\n<li>\nWhen are PMCF studies necessary?<\/li>\n<\/ul>\n<p>\n<strong>Quiz on clinical evaluation, clinical investigation and PMCF<\/strong><\/p>\n<p>\n<strong>New requirements of the MDR<\/strong><\/p>\n<ul>\n<li>\nSummary of safety and clinical performance<\/li>\n<li>\nPeriodic safety update report (PSUR)<\/li>\n<\/ul>\n<p>\n<strong>The competent authority and the Notified Body<\/strong><\/p>\n<ul>\n<li>\nWhat is their role in the above processes?<\/li>\n<li>\nWhat are the responsibilities of the manufacturer?<\/li>\n<li>\nWhat to communicate and when<\/li>\n<\/ul>\n<p>\n<strong>Workshop on the new requirements of the MDR<\/strong><\/p>\n<p>\n<strong>Vigilance reporting<\/strong><\/p>\n<ul>\n<li>\nWhat is vigilance?<\/li>\n<li>\nThe requirements for vigilance reporting during medical device studies<\/li>\n<\/ul>\n<p>\n<strong>How to define and classify adverse events<\/strong><\/p>\n<ul>\n<li>\nDefinitions<\/li>\n<li>\nTypes of events<\/li>\n<li>\nDetermining categories<\/li>\n<\/ul>\n<p>\n<strong>Vigilance workshop<\/strong><\/p>\n<p>\n<strong>The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies<\/strong><\/p>\n<ul>\n<li>\nMEDDEV guidance document<\/li>\n<li>\nISO14155 harmonised standard<\/li>\n<li>\nResponsibilities<\/li>\n<li>\nTemplates<\/li>\n<\/ul>\n<p>\n<strong>The MDR &#8211; clinical elements<\/strong><\/p>\n<ul>\n<li>\nFocus on changes in the clinical arena<\/li>\n<li>\nChapter 6: clinical evaluation and investigation<\/li>\n<li>\nAnnex 14: clinical evaluation and post-market clinical follow-up<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong><\/p>\n<p>\n<strong>Janette Benaddi<\/strong><\/p>\n<p>\nDirector of Clinical &amp; Consulting Europe<\/p>\n<p>\nNAMSA<\/p>\n<p>\nJanette Benaddi is a business mentor, international speaker\/trainer and consultant to the medical device industry. Janette has over 25 years&#8217; experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles.<\/p>\n<p>\nShe has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.<\/p>\n<p>\nJanette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director.<\/p>\n<p>\nJanette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5744426\/medical-device-studies-regulatory-requirements?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=3l9rdn&amp;utm_campaign=1835901+-+2+Day+Medical+Device+Regulatory+Requirements+and+Adverse+Event+Reporting+Training+Course+(May+25-26%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/ipu8kr<\/a><\/p>\n<p>\n<strong>About ResearchAndMarkets.com<\/strong><\/p>\n<p>\nResearchAndMarkets.com is the world&#8217;s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;i&#x6c;&#x74;&#111;&#x3a;p&#114;&#x65;&#115;&#x73;&#64;&#114;&#x65;s&#x65;a&#114;&#x63;h&#x61;&#x6e;&#100;&#x6d;a&#114;&#x6b;&#101;&#x74;s&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#x72;&#x65;&#x73;&#x73;&#x40;&#x72;&#x65;&#115;&#101;&#97;&#114;&#99;&#104;&#97;ndma&#x72;&#x6b;&#x65;&#x74;&#x73;&#x2e;&#x63;&#x6f;&#x6d;<\/a><\/p>\n<p>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/ CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/2-day-medical-device-regulatory-requirements-and-adverse-event-reporting-training-course-may-25-26-2023-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-55613","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>2 Day Medical Device Regulatory Requirements and Adverse Event Reporting Training Course (May 25-26, 2023) - ResearchAndMarkets.com - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/2-day-medical-device-regulatory-requirements-and-adverse-event-reporting-training-course-may-25-26-2023-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2 Day Medical Device Regulatory Requirements and Adverse Event Reporting Training Course (May 25-26, 2023) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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