{"id":4725,"date":"2025-05-03T11:15:58","date_gmt":"2025-05-03T15:15:58","guid":{"rendered":"https:\/\/mivado.com\/eshop\/shop\/preparing-and-submitting-summary-reports-for-marketed-drugs-and-natural-health-products\/"},"modified":"2026-10-03T14:59:50","modified_gmt":"2026-10-03T18:59:50","slug":"preparing-and-submitting-summary-reports-for-marketed-drugs-and-natural-health-products","status":"publish","type":"product","link":"https:\/\/mivado.com\/eshop\/eshop\/shop\/preparing-and-submitting-summary-reports-for-marketed-drugs-and-natural-health-products\/","title":{"rendered":"Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products"},"content":{"rendered":"<p class=\"whitespace-pre-wrap break-words\"><strong>Elevate your regulatory compliance with our comprehensive on-demand Training on &#8220;Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products (PSSR).&#8221;<\/strong><\/p>\n<p class=\"whitespace-pre-wrap break-words\">This training program is designed to equip regulatory affairs professionals with the knowledge and skills necessary to prepare and submit compliant summary reports for marketed drugs and natural health products in accordance with Health Canada&#8217;s guidance document. The training focuses on the regulatory requirements, reporting timelines, data collection methodologies, and documentation standards mandated by Health Canada for monitoring the safety profile of post-market products.<\/p>\n<h3>Learning Objectives<\/h3>\n<p class=\"whitespace-pre-wrap break-words\">By the end of this training, participants will be able to:<\/p>\n<ul class=\"[&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-decimal space-y-1.5 pl-7\">\n<li class=\"whitespace-normal break-words\">Understand the regulatory framework governing summary reporting requirements<\/li>\n<li class=\"whitespace-normal break-words\">Distinguish between different types of summary reports and their requirements<\/li>\n<li class=\"whitespace-normal break-words\">Collect and analyze appropriate data for inclusion in summary reports<\/li>\n<li class=\"whitespace-normal break-words\">Prepare comprehensive and compliant Annual Summary Reports (ASRs)<\/li>\n<li class=\"whitespace-normal break-words\">Respond effectively to requests for Issue-Related Summary Reports (IRSRs)<\/li>\n<\/ul>\n<h2 data-sourcepos=\"18:1-18:20\"><strong>Target Audience<\/strong><\/h2>\n<p data-sourcepos=\"20:1-20:94\">This training is designed for individuals involved in pharmacovigilance activities, including:<\/p>\n<ul data-sourcepos=\"22:1-28:0\">\n<li data-sourcepos=\"22:1-22:33\">Pharmacovigilance professionals<\/li>\n<li data-sourcepos=\"23:1-23:25\">Medical safety officers<\/li>\n<li data-sourcepos=\"24:1-24:32\">Regulatory affairs specialists<\/li>\n<li data-sourcepos=\"25:1-25:30\">Clinical research associates<\/li>\n<li data-sourcepos=\"26:1-26:17\">Medical writers<\/li>\n<li data-sourcepos=\"27:1-28:0\">Healthcare professionals involved in drug safety monitoring<\/li>\n<\/ul>\n<h2 data-sourcepos=\"29:1-29:21\"><strong>Training Modules<\/strong><\/h2>\n<ul>\n<li data-sourcepos=\"29:1-29:21\">Module 1: PSSR-Introduction<\/li>\n<li data-sourcepos=\"29:1-29:21\">Module 2: PSSR-Annual Summary Report<\/li>\n<li data-sourcepos=\"29:1-29:21\">Module 3: PSSR-Issue-Related Summary Reports<\/li>\n<li data-sourcepos=\"29:1-29:21\">Module 4:\u00a0 PSSR-Conclusion<\/li>\n<\/ul>\n<h2>Takeaway<\/h2>\n<p>Additional training documentation and certificates will be provided after the exam. Please note that a minimum score of 80% is required before the training certificate should be issued.<\/p>\n<h2>Author<\/h2>\n<p><a href=\"http:\/\/www.linkedin.com\/in\/kossi-molley-3534923\" target=\"_blank\" rel=\"noopener\">Kossi Molley (il\/he), Chemist, LSSBB; PMP<\/a><br \/>\nChartered Trainer of the Labour Market Partners Commission<\/p>\n<h3>Please<a href=\"https:\/\/mivado.com\/mgp\/contact\/\"> get in touch <\/a>with us for group training!<\/h3>\n","protected":false},"excerpt":{"rendered":"<p>This training program is designed to equip regulatory affairs professionals with the knowledge and skills necessary to prepare and submit compliant summary reports for marketed drugs and natural health products in accordance with Health Canada&#8217;s guidance document. The training focuses on the regulatory requirements, reporting timelines, data collection methodologies, and documentation standards mandated by Health Canada for monitoring the safety profile of post-market products.<\/p>\n","protected":false},"featured_media":4715,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[86],"product_tag":[167,151,93,156,152,161,90],"class_list":["post-4725","product","type-product","status-publish","has-post-thumbnail","product_cat-e-learning","product_tag-adverse-drug-reactions","product_tag-adverse-reaction","product_tag-bpf","product_tag-drugs-regulations","product_tag-pharmacovigilance","product_tag-reporting-adverse-reactions","product_tag-risque","first","instock","virtual","sold-individually","taxable","purchasable","product-type-simple"],"wps_subtitle":"","_links":{"self":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/product\/4725","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/comments?post=4725"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/media\/4715"}],"wp:attachment":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/media?parent=4725"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/product_brand?post=4725"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/product_cat?post=4725"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/product_tag?post=4725"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}