{"id":46585,"date":"2022-07-26T18:02:58","date_gmt":"2022-07-26T16:02:58","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/human-factors-and-usability-engineering-in-the-development-of-drug-delivery-products-training-course-london-united-kingdom-december-7-8-2022-researchandmarkets-com\/"},"modified":"2022-07-26T18:02:58","modified_gmt":"2022-07-26T16:02:58","slug":"human-factors-and-usability-engineering-in-the-development-of-drug-delivery-products-training-course-london-united-kingdom-december-7-8-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/human-factors-and-usability-engineering-in-the-development-of-drug-delivery-products-training-course-london-united-kingdom-december-7-8-2022-researchandmarkets-com\/","title":{"rendered":"Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (London, United Kingdom &#8211; December 7-8, 2022) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5589971\/human-factors-and-usability-engineering-in-the?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=skzf94&amp;utm_campaign=1731034+-+Human+Factors+and+Usability+Engineering+in+the+Development+of+Drug+Delivery+Products+Training+Course+(London%2C+United+Kingdom+-+December+7-8%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220726005823\/en\/1524607\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220726005823\/en\/1524607\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device to comply with the MDR.\n<\/p>\n<p>\nThe format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of the MDR, IEC 62366 and FDA Human Factors Guidance. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study.\n<\/p>\n<p>\n<strong>Why you should attend<\/strong>\n<\/p>\n<ul>\n<li>\nUnderstand the requirements of IEC 62366 and FDA Human Factors Guidance\n<\/li>\n<li>\nKnow how to provide the regulators with specific usability data for your device\n<\/li>\n<li>\nUnderstand human factors and the design process\n<\/li>\n<li>\nLearn how to validate combination products\n<\/li>\n<li>\nConsider human factors and risk\n<\/li>\n<li>\nDiscuss generic combination products &#8211; ANDAs and HF\n<\/li>\n<li>\nFind out what HF data FDA require for biosimilars\n<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<p>\n<strong>This event will be beneficial to those working in the following areas:<\/strong>\n<\/p>\n<ul>\n<li>\nEngineering and device development\n<\/li>\n<li>\nPackaging\n<\/li>\n<li>\nRegulatory affairs\n<\/li>\n<li>\nQuality systems\n<\/li>\n<li>\nQuality assurance\n<\/li>\n<li>\nRisk management\n<\/li>\n<li>\nMarketing\n<\/li>\n<li>\nUsability and human factors engineering\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>Legal and regulatory basis for HF<\/strong>\n<\/p>\n<ul>\n<li>\nUS and EU law &#8211; the place of HF\n<\/li>\n<li>\nInternational usability engineering (UE) standards\n<\/li>\n<li>\nHuman Factors Guidance &#8211; FDA and MHRA\n<\/li>\n<li>\nFDA and HF\n<\/li>\n<\/ul>\n<p>\n<strong>HF and the design process<\/strong>\n<\/p>\n<ul>\n<li>\nDesign inputs &#8211; how HF can guide your combination product design\n<\/li>\n<li>\nDesign verification &#8211; examples of formative work for combination products\n<\/li>\n<li>\nDesign review &#8211; how to use the outputs from formative work to feed into design review\n<\/li>\n<li>\nDesign validation &#8211; how HF fits in the design validation work\n<\/li>\n<\/ul>\n<p>\n<strong>Validation testing<\/strong>\n<\/p>\n<ul>\n<li>\nA detailed look at validating combination products\n<\/li>\n<li>\nObjectives, methods, analysis and reporting\n<\/li>\n<li>\nCommon problems with validation<\/p>\n<ul>\n<li>\nAnd how to avoid them\n<\/li>\n<\/ul>\n<\/li>\n<li>\nLatest FDA views on validation data for combination products\n<\/li>\n<\/ul>\n<p>\n<strong>HF and risk<\/strong>\n<\/p>\n<ul>\n<li>\nUse-related risk analysis (URRA)<\/p>\n<ul>\n<li>\nWhat it is, and how it differs from FMEAs\n<\/li>\n<\/ul>\n<\/li>\n<li>\nConstructing a URRA &#8211; a practical exercise for a combination product\n<\/li>\n<li>\nRisk control measures &#8211; how to use them, document them and provide evidence that they are effective\n<\/li>\n<li>\nResidual risk &#8211; how to do a residual risk analysis\n<\/li>\n<\/ul>\n<p>\n<strong>HF and the clinical trials programme<\/strong>\n<\/p>\n<ul>\n<li>\nHow and where HF activities work in relation to clinical trials\n<\/li>\n<li>\nDifferences between HF and clinical studies\n<\/li>\n<li>\nHow to gather usability data from your clinical programme\n<\/li>\n<\/ul>\n<p>\n<strong>UE process<\/strong>\n<\/p>\n<ul>\n<li>\nA practical, hands-on UE workshop, using a real combination product as an example\n<\/li>\n<\/ul>\n<p>\n<strong>Generic combination products &#8211; ANDAs and HF<\/strong>\n<\/p>\n<ul>\n<li>\nHF requirements for ANDA submissions\n<\/li>\n<li>\nCritical design attributes\n<\/li>\n<li>\nThe role of HF in determining substitutability\n<\/li>\n<li>\nThreshold analyses &#8211; latest FDA requirements\n<\/li>\n<li>\nComparative HF studies &#8211; what they are and how to run them\n<\/li>\n<\/ul>\n<p>\n<strong>Ethics and IRB<\/strong>\n<\/p>\n<ul>\n<li>\nWhen is IRB\/ethics approval necessary for HF studies?\n<\/li>\n<li>\nHuman subject protection during HF studies &#8211; risks and mitigations\n<\/li>\n<\/ul>\n<p>\n<strong>Platform devices<\/strong>\n<\/p>\n<ul>\n<li>\nSampling plans &#8211; who should you recruit if you don&#8217;t know what the drug will be?\n<\/li>\n<li>\nWhat HF data should you develop for your platform device?\n<\/li>\n<\/ul>\n<p>\n<strong>Sharps prevention &#8211; simulated clinical use testing<\/strong>\n<\/p>\n<ul>\n<li>\nHow to satisfy the FDA guidance on simulated use of sharps prevention features\n<\/li>\n<\/ul>\n<p>\n<strong>Biosimilars<\/strong>\n<\/p>\n<ul>\n<li>\nWhat HF data does the FDA want for biosimilars?\n<\/li>\n<li>\nHow do FDA review the human factors data for biosimilars?\u00a0\n<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong>\n<\/p>\n<p>\nRichard Featherstone<br \/>\n<br \/>Human Factors Director<br \/>\n<br \/>Medical Device Usability Limited\n<\/p>\n<p>\nRichard Featherstone is Human Factors Director of Medical Device Usability Limited, a specialist human factors consultancy that works exclusively with new and emerging medical technologies.\n<\/p>\n<p>\nHe has been designing and conducting human factors studies for over 10 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. He and the MDU team regularly test in the US, UK, Europe and Australia and undertake formative and summative testing for some of the world&#8217;s largest pharmaceutical and medical device companies as well as small start-ups.\n<\/p>\n<p>\nBased in Cambridge, MDU has grown rapidly to become Europe&#8217;s largest specialist medical HF consultancy with clients around the world. Over 10 years of testing has meant that Richard has built a considerable body of knowledge of the practical aspects of designing, undertaking and reporting of both types of testing.\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5589971\/human-factors-and-usability-engineering-in-the?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=skzf94&amp;utm_campaign=1731034+-+Human+Factors+and+Usability+Engineering+in+the+Development+of+Drug+Delivery+Products+Training+Course+(London%2C+United+Kingdom+-+December+7-8%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/373or2<\/a>\n<\/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=\"ma&#105;&#108;&#116;&#x6f;&#x3a;&#x70;&#x72;&#x65;ss&#64;&#114;&#101;&#x73;&#x65;&#x61;&#x72;&#x63;ha&#110;&#100;&#109;&#x61;&#x72;&#x6b;&#x65;&#x74;s&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;&#x72;&#101;&#x73;&#115;&#x40;&#114;&#x65;s&#x65;a&#x72;c&#x68;a&#110;&#x64;&#109;&#x61;&#114;&#x6b;&#101;&#x74;&#115;&#x2e;c&#x6f;m<\/a><br \/>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\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/human-factors-and-usability-engineering-in-the-development-of-drug-delivery-products-training-course-london-united-kingdom-december-7-8-2022-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-46585","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (London, United Kingdom - December 7-8, 2022) - 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\/human-factors-and-usability-engineering-in-the-development-of-drug-delivery-products-training-course-london-united-kingdom-december-7-8-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (London, United Kingdom - December 7-8, 2022) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for ... 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