{"id":49898,"date":"2022-10-21T12:01:48","date_gmt":"2022-10-21T10:01:48","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/european-post-marketing-pharmacovigilance-training-course-november-2-4-2022-researchandmarkets-com\/"},"modified":"2022-10-21T12:01:48","modified_gmt":"2022-10-21T10:01:48","slug":"european-post-marketing-pharmacovigilance-training-course-november-2-4-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/european-post-marketing-pharmacovigilance-training-course-november-2-4-2022-researchandmarkets-com\/","title":{"rendered":"European Post Marketing Pharmacovigilance Training Course (November 2-4, 2022) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5661711\/european-post-marketing-pharmacovigilance?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nthprl&amp;utm_campaign=1765263+-+European+Post+Marketing+Pharmacovigilance+Training+Course+(November+2-4%2C+2022)&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;European Post Marketing Pharmacovigilance &#8211; Including the EMA\/PRAC Deliberations and Brexit Implications Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221021005187\/en\/1609906\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221021005187\/en\/1609906\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.\n<\/p>\n<p>\nThe course intends to show how the safety of products is managed at the Regulatory Authority level, the interactions with Regulatory Bodies and Pharma, and the internal Pharma processes in managing the safety of the Company products from receiving safety cases\/information, all the way through to signal analysis and safety communication. All of this is viewed from a practical point of view for compliance and Key Performance Indicators (KPIs).\n<\/p>\n<p>\nThe European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) deliberations and Brexit implications will be discussed.\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<p>\nThis 3-day course is intended for those individuals from Europe and the USA, who need to understand EU Pharmacovigilance, it will be beneficial for those working in allied technical areas (Regulatory, Clinical, QA, and Auditing) who require an overview of key pharmacovigilance activities and also need to understand the many complexities of EU pharmacovigilance. All of these activities are discussed in relation to Quality Management Systems (QMS), audits and inspections.\n<\/p>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>An Introduction to the New PV Structure<\/strong>\n<\/p>\n<ul>\n<li>\nThe new Modules\n<\/li>\n<li>\nThe interaction of the Modules\n<\/li>\n<li>\nThe EU Modules &amp; ICH\n<\/li>\n<\/ul>\n<p>\n<strong>Quality Management Systems (QMS) (Module 1)<\/strong>\n<\/p>\n<ul>\n<li>\nQuality Control, Quality Assurance, and Quality Management\n<\/li>\n<li>\nQuality Management of PV systems\n<\/li>\n<li>\nThe QP PV and Quality Management\n<\/li>\n<li>\nQuality &amp; Training\n<\/li>\n<li>\nQA &amp; Quality Management &amp; internal audits\n<\/li>\n<\/ul>\n<p>\n<strong>The Pharmacovigilance Systems Master File (PSMF &#8211; Module II)<\/strong>\n<\/p>\n<ul>\n<li>\nThe content of the PV Master file\n<\/li>\n<li>\nLicence submissions and the PV Master file\n<\/li>\n<li>\nThe QP PV and the PV Master file\n<\/li>\n<li>\nControl\/Management of the PV Master file\n<\/li>\n<li>\nThe PSMF\/Annexes and Regulatory Inspections\n<\/li>\n<\/ul>\n<p>\n<strong>Pharmacovigilance Inspections (Module III)<\/strong>\n<\/p>\n<ul>\n<li>\nThe purpose of the Inspection\n<\/li>\n<li>\nTypes of Inspection\n<\/li>\n<li>\nInspection findings\n<\/li>\n<li>\nRe-Inspections\n<\/li>\n<\/ul>\n<p>\n<strong>Pharmacovigilance Audits (Module IV)<\/strong>\n<\/p>\n<ul>\n<li>\nThe purpose of Company audits\n<\/li>\n<li>\nAudit scheduling and risk assessments\n<\/li>\n<li>\nAudit outputs and findings\n<\/li>\n<li>\nAudit findings and their corrections &#8211; Root Cause Analysis, Corrective Action Plans, Completion and re-audits\/scheduling\n<\/li>\n<\/ul>\n<p>\n<strong>Risk Management Plans (RMPs &#8211; Module V)<\/strong>\n<\/p>\n<ul>\n<li>\nICH E2E &#8211; Pharmacovigilance Planning\n<\/li>\n<li>\nThe RMP purpose in Europe\n<\/li>\n<li>\nThe RMP format &#8211; Generic products v Innovator\n<\/li>\n<li>\nUpdating the RMP\n<\/li>\n<li>\nRMPs &amp; REMs\n<\/li>\n<\/ul>\n<p>\n<strong>Adverse Reaction Reporting &#8211; Part 1 (Module VI)<\/strong>\n<\/p>\n<ul>\n<li>\nDefinitions\n<\/li>\n<li>\nSpecial Situations\n<\/li>\n<li>\nIMEs and DMEs\n<\/li>\n<li>\nTriage &#8211; Seriousness\n<\/li>\n<li>\nExpectedness and Causality\n<\/li>\n<li>\nExpedited reporting (including Country specific v EMA)\n<\/li>\n<\/ul>\n<p>\n<strong>Adverse reaction Reporting &#8211; Part 2 (Module VI)<\/strong>\n<\/p>\n<ul>\n<li>\nElectronic ADR reporting local &amp; International\n<\/li>\n<li>\nFollow up of cases\n<\/li>\n<li>\nICH E2D &#8211; Post Marketing Safety\n<\/li>\n<li>\nLiterature ADR reporting\n<\/li>\n<li>\nCase Closure\n<\/li>\n<\/ul>\n<p>\n<strong>PBRERs (Module VII)<\/strong>\n<\/p>\n<ul>\n<li>\nICH E2F &amp; ICH E2C (R2) &#8211; DSURs &amp; PSURs\/PBRERs\n<\/li>\n<li>\nObjectives of the PSURs\n<\/li>\n<li>\nRisk Benefit Analyses in PSURs\n<\/li>\n<li>\nThe format of the PSUR\n<\/li>\n<li>\nMapping Signals and Risks to the PSUR\n<\/li>\n<\/ul>\n<p>\n<strong>Signals and their Management (Module IX)<\/strong>\n<\/p>\n<ul>\n<li>\nWhat is a signal?\n<\/li>\n<li>\nSignal Scheduling\n<\/li>\n<li>\nSignal validation\n<\/li>\n<li>\nSignal analysis and prioritisation\n<\/li>\n<li>\nSignal Assessment\n<\/li>\n<li>\nEVDAS and signalling\n<\/li>\n<li>\nActions to be taken\n<\/li>\n<\/ul>\n<p>\n<strong>Post-Authorisation Safety Studies (PASS) (Module VIII &amp; Addendum)<\/strong>\n<\/p>\n<ul>\n<li>\nThe need for PASS\n<\/li>\n<li>\nThe design of the PASS\n<\/li>\n<li>\nResults from the PASS &amp; RMPs\n<\/li>\n<li>\nPost Authorisation Efficacy Studies\n<\/li>\n<\/ul>\n<p>\n<strong>Additional Monitoring (Module X)<\/strong>\n<\/p>\n<ul>\n<li>\nThe purpose of additional monitoring for products\n<\/li>\n<li>\nWhat needs to be done?\n<\/li>\n<li>\nMandatory &amp; Optional aspects of additional monitoring\n<\/li>\n<li>\nThe role of the MAH in additional monitoring\n<\/li>\n<\/ul>\n<p>\n<strong>Risk Minimisation (RM) Measures and Tools<\/strong>\n<\/p>\n<ul>\n<li>\nRisk Minimisation measures\n<\/li>\n<li>\nEducational Tools\n<\/li>\n<li>\nControlled Access programmes\n<\/li>\n<li>\nOther RM techniques\n<\/li>\n<\/ul>\n<p>\n<strong>Urgent Safety Restrictions &amp; Safety Communications (Modules VI, IX and XV)<\/strong>\n<\/p>\n<ul>\n<li>\nSafety Communications to the Regulatory Authorities\n<\/li>\n<li>\nProcess for Urgent Safety Restrictions\n<\/li>\n<li>\nWhat Safety Communication and where\n<\/li>\n<li>\nApproval and Monitoring of Safety Communications\n<\/li>\n<\/ul>\n<p>\n<strong>The EU QP PV &amp; Local (National) QP PVs &#8211; Modules I &amp; II &#8211; Knowledge &amp; Oversight<\/strong>\n<\/p>\n<ul>\n<li>\nThe roles and responsibilities of the EU QP PV\n<\/li>\n<li>\nKnowledge of the EU QP PV\n<\/li>\n<li>\nThe EU QP PV and Regulatory Inspections\n<\/li>\n<li>\nThe EU QP PV &amp; Local (QP PVs\/Responsible Person)\n<\/li>\n<li>\nBrexit &#8211; The UK QP PV\n<\/li>\n<\/ul>\n<p>\n<strong>Speaker<\/strong>\n<\/p>\n<p>\nGraeme Ladds\n<\/p>\n<p>\nDirector\n<\/p>\n<p>\nPharSafer Associates Ltd.\n<\/p>\n<p>\nGraeme Ladds, Director of PharSafer, has over 22 years&#8217; experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety &amp; Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.\n<\/p>\n<p>\nThe last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5661711\/european-post-marketing-pharmacovigilance?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nthprl&amp;utm_campaign=1765263+-+European+Post+Marketing+Pharmacovigilance+Training+Course+(November+2-4%2C+2022)&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/wa5utd<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;t&#x6f;&#58;&#x70;&#114;e&#x73;&#115;&#x40;&#114;e&#x73;&#101;&#x61;&#x72;c&#x68;&#97;n&#x64;&#109;&#x61;&#114;k&#x65;&#116;&#x73;&#46;c&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;&#x72;&#x65;s&#115;&#x40;r&#101;&#x73;&#x65;&#97;&#x72;&#x63;h&#97;&#x6e;d&#109;&#x61;&#x72;&#107;&#x65;&#x74;s&#46;&#x63;o&#109;<\/a><\/p>\n<p>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/ CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;European Post Marketing Pharmacovigilance &#8211; Including the EMA\/PRAC Deliberations and Brexit Implications Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/european-post-marketing-pharmacovigilance-training-course-november-2-4-2022-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-49898","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>European Post Marketing Pharmacovigilance Training Course (November 2-4, 2022) - ResearchAndMarkets.com - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/european-post-marketing-pharmacovigilance-training-course-november-2-4-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Post Marketing Pharmacovigilance Training Course (November 2-4, 2022) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;European Post Marketing Pharmacovigilance &#8211; Including the EMA\/PRAC Deliberations and Brexit Implications Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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Including the EMA\/PRAC Deliberations and Brexit Implications Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 ... 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