{"id":44854,"date":"2022-06-08T17:01:59","date_gmt":"2022-06-08T15:01:59","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-2022-researchandmarkets-com\/"},"modified":"2022-06-08T17:01:59","modified_gmt":"2022-06-08T15:01:59","slug":"2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-2022-researchandmarkets-com\/","title":{"rendered":"2 Day Virtual Drug Development and Regulatory Approval Process Course: Key to Success from Concept to Commercialization Course &#8211; July 7th-8th, 2022 &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5596004\/drug-development-key-to-success-from-concept-to?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=4gth7z&amp;utm_campaign=1710770+-+2+Day+Virtual+Drug+Development+and+Regulatory+Approval+Process+Course%3A+Key+to+Success+from+Concept+to+Commercialization+Course+-+July+7th-8th%2C+2022&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Drug Development: Key to Success from Concept to Commercialization Course&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220608005855\/en\/1480660\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220608005855\/en\/1480660\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThe course begins by considering the global pharmaceutical market, important therapeutic areas and the roles of different Pharmaceutical professionals in the development process, as well as a definition of drugs and medical devices.\n<\/p>\n<p>\nCourse includes the identification of drug targets, synthesis of chemical drugs and the development of biologics, pharmacokinetics and toxicity screening, pre-clinical development, clinical studies, regulatory submissions, managing post-approval change, pharmacovigilance and an overview of regulations governing drug manufacture and distribution.\n<\/p>\n<p>\nThe drug development process, from discovery to post-marketing surveillance, is then explained. This course is designed to teach employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process.\n<\/p>\n<p>\n<strong>Learning Objectives:<\/strong>\n<\/p>\n<ul>\n<li>\nRoles of different pharmaceutical professionals\n<\/li>\n<li>\nTypical costs and timelines associated with drug development\n<\/li>\n<li>\nHow new drugs are developed against targets in the human body\n<\/li>\n<li>\nThe structure of regulatory submissions\n<\/li>\n<li>\nReasons why drugs fail during development process\n<\/li>\n<li>\nFactors affecting oral bioavailability\n<\/li>\n<li>\nThe size of the global pharmaceutical market and the key therapeutic areas being addressed by innovator companies\n<\/li>\n<li>\nHow drugs are screened for toxicity\n<\/li>\n<li>\nThe potential influence of polymorphism, salt form and isomerism on efficacy and safety\n<\/li>\n<li>\nHow formulation can affect drug performance\n<\/li>\n<li>\nHow the safety and efficacy of drug products are ensured during QC release testing\n<\/li>\n<li>\nThe information obtained at each stage of clinical research\n<\/li>\n<li>\nHow post-approval changes to drug products are managed\n<\/li>\n<li>\nHow the manufacture and distribution of marketed drug products are controlled\n<\/li>\n<\/ul>\n<p>\n<strong>Agenda<\/strong>\n<\/p>\n<p>\n<strong>Drug Development Products Overview<\/strong>\n<\/p>\n<ul>\n<li>\nProduct types and routes of administration\n<\/li>\n<li>\nThe drug development process\n<\/li>\n<li>\nRisks in drug development\n<\/li>\n<\/ul>\n<p>\n<strong>The International pharmaceutical market<\/strong>\n<\/p>\n<ul>\n<li>\nMarket shares of chemical and biological drugs\n<\/li>\n<li>\nRoles of drug development professionals\n<\/li>\n<li>\nSize and key therapeutic areas\n<\/li>\n<li>\nRegional differences\n<\/li>\n<\/ul>\n<p>\n<strong>Drug discovery<\/strong>\n<\/p>\n<ul>\n<li>\nDrug targets\n<\/li>\n<li>\nThe Human Genome Project\n<\/li>\n<li>\nLead compound identification and optimisation\n<\/li>\n<\/ul>\n<p>\n<strong>Break<\/strong>\n<\/p>\n<p>\n<strong>Regulatory submissions<\/strong>\n<\/p>\n<ul>\n<li>\nThe Common Technical Document\n<\/li>\n<li>\nCTD modules\n<\/li>\n<li>\nRegional administrative information\n<\/li>\n<li>\nThe application process for chemical and biologic drug products &#8211; US and EU\n<\/li>\n<\/ul>\n<p>\n<strong>Break<\/strong>\n<\/p>\n<p>\n<strong>Pre-clinical development<\/strong>\n<\/p>\n<ul>\n<li>\nOptical isomerism\n<\/li>\n<li>\nFormulation options for improving bioavailability\n<\/li>\n<li>\nCommon formulation types\n<\/li>\n<li>\nCritical quality attributes\n<\/li>\n<li>\nIn-process controls and release testing\n<\/li>\n<li>\nPolymorph and salt form screening\n<\/li>\n<li>\nSolubility, permeability and oral bioavailability\n<\/li>\n<\/ul>\n<p>\n<strong>Clinical research<\/strong>\n<\/p>\n<ul>\n<li>\nClinical study design\n<\/li>\n<li>\nClinical development Phases\n<\/li>\n<li>\nEstablishing safety and efficacy\/bio equivalence\n<\/li>\n<li>\nAdverse event reporting\n<\/li>\n<li>\nImpact of mobile computing on clinical research\n<\/li>\n<\/ul>\n<p>\n<strong>Pharmacokinetics and toxicity<\/strong>\n<\/p>\n<ul>\n<li>\nDrug plasma concentration profiles\n<\/li>\n<li>\nAbsorption, distribution, metabolism and elimination of drugs\n<\/li>\n<li>\nFirst-pass metabolism\n<\/li>\n<li>\nTypes of toxicity screening\n<\/li>\n<\/ul>\n<p>\n<strong>Break 15 mins<\/strong>\n<\/p>\n<p>\n<strong>Post-approval change<\/strong>\n<\/p>\n<ul>\n<li>\nProblems concerning product improvement\n<\/li>\n<li>\nNew ICH Q12 &#8211; the promise of easier post-approval change\n<\/li>\n<li>\nCurrent situation\n<\/li>\n<\/ul>\n<p>\n<strong>US and EU Pharmacovigilance<\/strong>\n<\/p>\n<p>\n<strong>Important elements of regulation<\/strong>\n<\/p>\n<ul>\n<li>\nDrug product manufacture\n<\/li>\n<li>\nDistribution\n<\/li>\n<li>\nICH guidance\n<\/li>\n<\/ul>\n<p>\n<strong>Final questions, feedback and close<\/strong>\n<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5596004\/drug-development-key-to-success-from-concept-to?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=4gth7z&amp;utm_campaign=1710770+-+2+Day+Virtual+Drug+Development+and+Regulatory+Approval+Process+Course%3A+Key+to+Success+from+Concept+to+Commercialization+Course+-+July+7th-8th%2C+2022&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/bjnbt5<\/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=\"&#x6d;a&#x69;&#108;&#x74;&#111;:&#x70;r&#x65;&#115;&#x73;&#64;r&#x65;&#115;&#x65;&#97;r&#x63;h&#x61;&#110;&#x64;&#109;a&#x72;k&#x65;&#116;&#x73;&#x2e;c&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">p&#114;&#x65;&#x73;s&#64;&#114;&#x65;&#x73;e&#97;&#x72;&#x63;h&#97;&#110;&#x64;&#x6d;a&#114;&#x6b;&#x65;t&#115;&#46;&#x63;&#x6f;m<\/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\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Drug Development: Key to Success from Concept to Commercialization Course&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. The course begins by considering the global pharmaceutical market, important therapeutic areas and the roles of different Pharmaceutical professionals in the development process, as well as a definition of drugs and medical devices. Course includes the &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-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-44854","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>2 Day Virtual Drug Development and Regulatory Approval Process Course: Key to Success from Concept to Commercialization Course - July 7th-8th, 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\/2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-2022-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 Virtual Drug Development and Regulatory Approval Process Course: Key to Success from Concept to Commercialization Course - July 7th-8th, 2022 - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Drug Development: Key to Success from Concept to Commercialization Course&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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[Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-08T15:01:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20220608005855\/en\/1480660\/21\/logo.jpg\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-2022-researchandmarkets-com\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/2-day-virtual-drug-development-and-regulatory-approval-process-course-key-to-success-from-concept-to-commercialization-course-july-7th-8th-2022-researchandmarkets-com\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"2 Day Virtual Drug Development and Regulatory Approval Process Course: Key to Success from Concept to Commercialization Course &#8211; 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