{"id":34009,"date":"2016-03-22T13:23:14","date_gmt":"2016-03-22T12:23:14","guid":{"rendered":"https:\/\/swedenbio.se\/kalendarium\/introduction-to-regulatory-affairs\/"},"modified":"2023-10-11T09:30:44","modified_gmt":"2023-10-11T07:30:44","slug":"introduction-to-regulatory-affairs","status":"publish","type":"sb_events","link":"https:\/\/swedenbio.se\/en\/kalendarium\/introduction-to-regulatory-affairs\/","title":{"rendered":"Introduction to Regulatory Affairs"},"content":{"rendered":"<p>This is the training day for those who need an up-to-date overview of current regulations and how to ensure adequate regulatory documentation in all phases of a drug development project with a focus on early phase.<\/p>\n<p><b>The course will be held on four occasions in Ume\u00e5, Link\u00f6ping, Lund and Stockholm in 2016.<\/b><\/p>\n<p><b>Target group  <\/b><\/p>\n<p>The training day is primarily aimed at those who work in the smaller research-based pharmaceutical company and need comprehensive knowledge of Regulatory Affairs: project managers, project team members, innovators and entrepreneurs, academic researchers, drug developers and management working in research-based pharmaceutical companies.<\/p>\n<p><b>Course objectives  <\/b><\/p>\n<p>The training day provides an overview of the field of Regulatory Affairs, to give you an understanding of the regulatory requirements you may face in drug development.<\/p>\n<p><b>Course content and structure  <\/b><\/p>\n<p>The training day is structured around lectures. As a participant, you will be given the opportunity to submit in advance any questions you wish to have addressed. This will be addressed during the course:<\/p>\n<ul>\n<li>Innovation support<\/li>\n<li>Terminology and regulations<\/li>\n<li>Application for authorization of a medicinal product<\/li>\n<li>The role of Regulatory Affairs in drug development<\/li>\n<li>Clinical trials\/regulations and authorizations<\/li>\n<li>Product life cycle<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This is the training day for those who need an up-to-date overview of current regulations and how to ensure adequate regulatory documentation in all phases of a drug development project with a focus on early phase. The course will be held on four occasions in Ume\u00e5, Link\u00f6ping, Lund and Stockholm in 2016. Target group The [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"sb_event-category":[],"class_list":["post-34009","sb_events","type-sb_events","status-publish","hentry"],"acf":[],"aioseo_notices":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Introduction to Regulatory Affairs - SwedenBIO<\/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:\/\/swedenbio.se\/en\/kalendarium\/introduction-to-regulatory-affairs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Introduction to Regulatory Affairs - SwedenBIO\" \/>\n<meta property=\"og:description\" content=\"This is the training day for those who need an up-to-date overview of current regulations and how to ensure adequate regulatory documentation in all phases of a drug development project with a focus on early phase. 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