{"id":6077,"date":"2023-07-17T10:58:54","date_gmt":"2023-07-17T08:58:54","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&#038;p=6077"},"modified":"2026-06-09T10:11:30","modified_gmt":"2026-06-09T08:11:30","slug":"sdea-in-pharmacovigilance","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharmacovigilance\/sdea-in-pharmacovigilance\/","title":{"rendered":"Safety Data Exchange Agreements (SDEA) in Pharmacovigilance: training course +workshop"},"content":{"rendered":"<div class=\"et_pb_row_inner et_pb_row_inner_1\">\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_inner et_pb_column_inner_2 et-last-child\">\n<div class=\"et_pb_module et_pb_text et_pb_text_1 et_pb_text_align_justified et_pb_bg_layout_light\">\n<div class=\"et_pb_text_inner\">\n<p>Effective management of pharmacovigilance aspects in commercial agreements is essential for all parties involved and ensures compliance with drug regulatory requirements. Therefore, commercial agreements between companies must be set up considering possible interactions with pharmacovigilance and possibly supplemented by agreements (commonly: &#8220;Safety Data Exchange Agreement&#8221;) that define the Pharmacovigilance obligations of the contracting Companies.<\/p>\n<p>The training course \u201cSafety Data Exchange Agreements (SDEA) in Pharmacovigilance\u201d is of interest to personnel involved in the negotiation, drafting and management of pharmacovigilance agreements of various types (e.g., co-marketing, distribution, licensing, services), but also to those working in regulatory affairs, marketing, and legal departments. This seminar, with an interactive focus and including a workshop to put the theoretical concepts explained into practice, addresses the main regulatory requirements for pharmacovigilance by indicating the main terms to be included in different types of agreements, in order to ensure regulatory compliance with a practical approach to drafting and maintaining such agreements.<\/p>\n<p><strong>Would you like to participate, but you&#8217;re not available on this date?<\/strong><br \/>\nThe course will be provided again:<\/p>\n<ul>\n<li>September 24th 2024<\/li>\n<li>March 6th 2025<\/li>\n<\/ul>\n<p>(*) Contact us via email or phone to enroll.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Effective management of pharmacovigilance aspects in commercial agreements is essential for all parties involved and ensures compliance with drug regulatory requirements.<\/p>\n","protected":false},"featured_media":6085,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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SESSION\r\n<h5>Program<\/h5>\r\n<div class=\"et_pb_section et_pb_section_4 et_section_regular\">\r\n<div class=\"et_pb_row et_pb_row_2\">\r\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_4 et_pb_css_mix_blend_mode_passthrough et-last-child\">\r\n<div class=\"et_pb_module et_pb_tabs et_pb_tabs_0 et_slide_transition_to_3 et_slide_transition_to_0\">\r\n<div class=\"et_pb_all_tabs\">\r\n<div class=\"et_pb_tab et_pb_tab_0 clearfix et_pb_active_content et-pb-active-slide\">\r\n<div class=\"et_pb_tab_content\">\r\n<ul>\r\n \t<li>Contractual agreements: definitions and relevant legislation:\r\n<ul>\r\n \t<li>Types of agreements<\/li>\r\n \t<li>Definitions<\/li>\r\n \t<li>GVP References<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Contents of the Safety Data Exchange Agreement:\r\n<ul>\r\n \t<li>Background<\/li>\r\n \t<li>Technical clauses and common clauses<\/li>\r\n \t<li>Templates<\/li>\r\n \t<li>Attachments<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Management of SDEAs:\r\n<ul>\r\n \t<li>Tracking system<\/li>\r\n \t<li>Verification of commitments made<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Q&amp;A Session<\/li>\r\n \t<li>Interactive Session:\r\n<ul>\r\n \t<li>Setting up a pharmacovigilance agreement: each participant will set up a specific type of pharmacovigilance agreement; the drafts will then be reviewed and commented on with all participants, highlighting any errors made and suggesting optimal alternative solutions.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Final discussion and conclusion of the day<\/li>\r\n<\/ul>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_target":"<div class=\"et_pb_section et_pb_section_3 et_section_regular\">\r\n<div class=\"et_pb_row et_pb_row_1\">\r\n<div class=\"et_pb_column et_pb_column_4_4 et_pb_column_3 et_pb_css_mix_blend_mode_passthrough et-last-child\">\r\n<div class=\"et_pb_module et_pb_tabs et_pb_tabs_0 et_slide_transition_to_3 et_slide_transition_to_0 et_slide_transition_to_1\">\r\n<div 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Marketing.\r\n\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_competenze":[{"corso_competenze_item":"Distinguish the main types of commercial agreements"},{"corso_competenze_item":"Know the updated reference legislation on contract management in Pharmacovigilance"},{"corso_competenze_item":"Identify formats and contents of the SDEA"},{"corso_competenze_item":"Write a SDEA in accordance with regulatory requirements"},{"corso_competenze_item":"Practical implications in the management of 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