{"id":6118,"date":"2023-05-22T10:15:21","date_gmt":"2023-05-22T08:15:21","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/uncategorized\/pharmacovigilance-system-master-file\/"},"modified":"2026-01-14T11:06:43","modified_gmt":"2026-01-14T10:06:43","slug":"pharmacovigilance-system-master-file","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharmacovigilance\/pharmacovigilance-system-master-file\/","title":{"rendered":"Pharmacovigilance System Master File (PSMF)"},"content":{"rendered":"<p>The Pharmacovigilance System Master File (PSMF) is the key tool for managing the corporate pharmacovigilance system and supporting oversight by the QPPV. The objective of the course is to present the relevant regulations and analyze the PSMF by examining its format, content, and how it is written, archived, and maintained. The course also includes an overview of the main deviations found during inspection.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Pharmacovigilance System Master File (PSMF) is the key tool for managing the corporate pharmacovigilance system and supporting oversight by the 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SESSION\r\n<ol>\r\n \t<li>Introduction<\/li>\r\n<\/ol>\r\nRegulatory bases:\r\n<ul>\r\n \t<li>Directive 2010\/84\/EU and EU Regulation 1235\/2010.<\/li>\r\n \t<li>The EU Implementing Regulation 520\/2012<\/li>\r\n \t<li>The Module II of the Good Pharmacovigilance Practice Guide<\/li>\r\n \t<li>The Ministerial Decree of April 30, 2015<\/li>\r\n \t<li>Objectives of the PSMF and key concepts for the management of all PSMF-related activities<\/li>\r\n \t<li>Registration and Maintenance (Form 1.8.1, localization, data recording in XEVMPD,...)<\/li>\r\n \t<li>Transfer of Responsibility (delegation of responsibilities\/activities)<\/li>\r\n<\/ul>\r\n<ol start=\"2\">\r\n \t<li>Structure of the PSMF (CORE and Annexes).<\/li>\r\n<\/ol>\r\nDescription of the content and form of the PSMF: the main body and annexes and presentation of practical examples\r\n<ol start=\"3\">\r\n \t<li>Management of the PSMF<\/li>\r\n<\/ol>\r\n<ul>\r\n \t<li>Management of updates and revisions<\/li>\r\n \t<li>Interaction with other departments\/partners for retrieval and transposition of information relevant to the PSMF<\/li>\r\n \t<li>Accessibility and distribution<\/li>\r\n<\/ul>\r\n<ol start=\"4\">\r\n \t<li>Deviations most commonly encountered during inspections by Regulatory Authority.<\/li>\r\n<\/ol>","corso_target":"Operators in pharmaceutical companies with knowledge of pharmacovigilance who are involved or will be involved in the implementation and\/or maintenance of the PSMF. 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