<\/p>\n
The EU Directive 2010\/84\/EU (amending 2001\/83\/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA.<\/p>\n
Any company that has at least one pharmaceutical product approved in the European Union is therefore required to have a PSMF in place.<\/p>\n
The PSMF gives regulators a complete description and assessment of the full pharmacovigilance system, and the annexes’ outputs help them determine how well a company is complying.<\/p>\n
To ensure compliance, this training will provide practical guidance to developing, drafting, maintaining, and updating the PSMF.<\/p>\n
The sessions will also discuss the PSMF’s importance in regulatory inspections, as well as common PSMF inspection findings.<\/p>\n","protected":false},"excerpt":{"rendered":"
The PSMF (Pharmacovigilance System Master File): from GVPs to Inspections The EU Directive 2010\/84\/EU (amending 2001\/83\/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA. Any company that has at least one … Continued<\/a><\/p>\n","protected":false},"featured_media":7857,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-19976","product","type-product","status-publish","has-post-thumbnail","course_topics-farmacovigilanza","course_types-corso-online","productgroup-the-psmf-pharmacovigilance-system-master-file-from-gvps-to-inspections","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product\/19976","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media\/7857"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media?parent=19976"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_brand?post=19976"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_cat?post=19976"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_tag?post=19976"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}