{"id":7620,"date":"2021-11-10T10:08:21","date_gmt":"2021-11-10T09:08:21","guid":{"rendered":"http:\/\/lsacademy.com\/?post_type=product&#038;p=7620"},"modified":"2022-03-15T17:15:10","modified_gmt":"2022-03-15T16:15:10","slug":"safety-in-clinical-trial-under-the-clinical-trial-regulation-eu-no-536-2014","status":"publish","type":"product","link":"https:\/\/lsacademy.site-dev.it\/it\/product\/safety-in-clinical-trial-under-the-clinical-trial-regulation-eu-no-536-2014\/","title":{"rendered":"Safety in Clinical Trial under the Clinical Trial Regulation (EU) No 536\/2014"},"content":{"rendered":"<p>The course will explain the impact of the Clinical Trial Regulation (EU) No 536\/2014 on the regulatory and assessment procedures of the safety in clinical trials. Participants will be guided into the regulatory aspects of the major clinical trial application documents and the discussion will cover the rules for safety reporting, tips and tricks for submission of clinical trial application and the substantial modification on the ASR.<\/p>\n<p>The course will address:<\/p>\n<ul>\n<li>Safety regulatory and assessment procedures under the CTR in a transition period<\/li>\n<li>Main point to consider related to CTR Q&amp;A document<\/li>\n<li>Regulatory expectations for a Clinical Trial Application (CTA) submission and modifications during the developmental cycle (Phase I to Phase IV) in safety documents such as Investigator\u00e2\u20ac\u2122s Brochure (IB), Reference Safety Information (RSI), protocol<\/li>\n<li>Regulatory expectations for an Annual Safety Report (ASR) submission<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>The course will explain the impact of the Clinical Trial Regulation (EU) No 536\/2014 on the regulatory and assessment procedures of the safety in clinical trials. Participants will be guided into the regulatory aspects of the major clinical trial application documents and the discussion will cover the rules for safety reporting, tips and tricks for &hellip; <a href=\"https:\/\/lsacademy.site-dev.it\/it\/product\/safety-in-clinical-trial-under-the-clinical-trial-regulation-eu-no-536-2014\/\">Continued<\/a><\/p>\n","protected":false},"featured_media":7624,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":{"0":"post-7620","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"course_topics-farmacovigilanza","7":"course_topics-regolatorio","8":"course_types-corso-online","9":"productgroup-safety-in-clinical-trial-under-the-clinical-trial-regulation-eu-no-536-2014","10":"product_cat-corsi","12":"first","13":"instock","14":"taxable","15":"shipping-taxable","16":"purchasable","17":"product-type-variable"},"_links":{"self":[{"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/product\/7620","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/media\/7624"}],"wp:attachment":[{"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/media?parent=7620"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/product_brand?post=7620"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/product_cat?post=7620"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.site-dev.it\/it\/wp-json\/wp\/v2\/product_tag?post=7620"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}