Many sponsors and academic groups have been navigating the evolving landscape of clinical trial safety in the European Economic Area (EEA) since the EU Clinical Trials Regulation (Reg. (EU) No. 536\/2014, EU CTR) came into force.<\/p>\n
Yet, ensuring a trial is authorized or transitioned in CTIS is only the beginning.<\/p>\n
The EU CTR\u2019s safety provisions reach far beyond initial submissions, fundamentally shaping ongoing safety management, reporting, and operational processes throughout the trial lifecycle.<\/p>\n
Are your teams confident in distinguishing between IMPs and AxMPs, and in applying the latest definitions for adverse events and serious adverse reactions?
\nDo you know how to construct, update, and implement Reference Safety Information (RSI) in line with both regulatory and operational realities?
\nAre your safety reporting workflows, risk mitigation strategies, and communication plans robust enough to withstand regulatory scrutiny and inspection?<\/p>\n","protected":false},"excerpt":{"rendered":"
Advanced Safety Management in Clinical Trials under CTR 536\/2014 Many sponsors and academic groups have been navigating the evolving landscape of clinical trial safety in the European Economic Area (EEA) since the EU Clinical Trials Regulation (Reg. (EU) No. 536\/2014, EU CTR) came into force. Yet, ensuring a trial is authorized or transitioned in CTIS … Continued<\/a><\/p>\n","protected":false},"featured_media":19329,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-19324","product","type-product","status-publish","has-post-thumbnail","course_topics-farmacovigilanza","course_topics-regolatorio","course_types-corso-online","productgroup-advanced-safety-management-in-clinical-trials-under-ctr-536-2014","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product\/19324","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media\/19329"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media?parent=19324"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=19324"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=19324"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=19324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}