{"id":15504,"date":"2026-01-30T11:13:30","date_gmt":"2026-01-30T10:13:30","guid":{"rendered":"https:\/\/semmelweis.hu\/pharmacology\/?page_id=15504"},"modified":"2026-04-14T16:23:20","modified_gmt":"2026-04-14T14:23:20","slug":"gvpcoursebysemmelweisuniversity","status":"publish","type":"page","link":"https:\/\/semmelweis.hu\/pharmacology\/en\/education\/postgraduate-courses\/gvpcoursebysemmelweisuniversity\/","title":{"rendered":"7th Good Vigilance Practice (GVP) Course \u2013 Semmelweis University"},"content":{"rendered":"<p><strong>Master EU Pharmacovigilance with Confidence<\/strong><\/p>\n<p>The 7th Good Vigilance Practice (GVP) Course organized by Semmelweis University delivers a comprehensive, practice-oriented training on European Union pharmacovigilance requirements. The program is fully aligned with current EU GVP legislation and focuses on both regulatory compliance and real-world implementation.<\/p>\n<p><strong>Why This Course Matters<\/strong><\/p>\n<p>Pharmacovigilance is a rapidly evolving regulatory field. This course provides a structured, end-to-end overview of all EU GVP Modules, complemented by insights into emerging trends, novel regulatory challenges, and high-impact developments shaping pharmacovigilance today.<\/p>\n<p>Participants gain not only theoretical knowledge, but also practical guidance directly applicable to daily pharmacovigilance activities.<\/p>\n<p><strong>Comprehensive Curriculum Covering All GVP Modules<\/strong><\/p>\n<p>The curriculum includes a detailed review of all EU-level pharmacovigilance legislation and GVP Modules, delivered in a logical and easy-to-follow structure.<\/p>\n<p><strong>Core Topics<\/strong><\/p>\n<ul>\n<li>Full overview of EU GVP Modules (I\u2013XVI)<\/li>\n<li>Roles and responsibilities within pharmacovigilance systems<\/li>\n<li>Signal management, risk management, and benefit\u2013risk evaluation<\/li>\n<li>Pharmacovigilance system management and oversight<\/li>\n<\/ul>\n<p><strong>Extended &amp; Emerging Topics<\/strong><\/p>\n<ul>\n<li>Medical device vigilance and interface with pharmacovigilance<\/li>\n<li>Pharmacovigilance inspections and audit readiness<\/li>\n<li>Latest academic research and scientific developments<\/li>\n<li>Emerging regulatory expectations and future trends<\/li>\n<\/ul>\n<p><strong>Expert-Led Training<\/strong><\/p>\n<p>All modules are delivered by a distinguished faculty of regulatory authority representatives and senior industry experts. This ensures that participants benefit from:<\/p>\n<ul>\n<li>First-hand regulatory insight<\/li>\n<li>Practical industry perspectives<\/li>\n<li>Real-world case examples and best practices<\/li>\n<\/ul>\n<p><strong>Who Should Attend?<\/strong><\/p>\n<p>This course is primarily designed for pharmacovigilance professionals, but it also offers significant value for experts working in related disciplines:<\/p>\n<ul>\n<li>Pharmacovigilance specialists and safety scientists<\/li>\n<li>Regulatory affairs professionals<\/li>\n<li>Medical affairs professionals<\/li>\n<li>Quality assurance and compliance experts<\/li>\n<li>Healthcare professionals involved in patient safety<\/li>\n<\/ul>\n<p>The content is suitable for both experienced professionals seeking an update and those aiming to strengthen their regulatory foundation.<\/p>\n<p><strong>Industry-Recognized Certification<\/strong><\/p>\n<p>Upon successful completion of the course, participants receive a certificate recognized by the pharmaceutical industry, confirming their knowledge of EU Good Vigilance Practice (GVP).<\/p>\n<p>The certificate is also accepted as external pharmacovigilance training, supporting<strong> regulatory compliance, audits, and continuous professional development.<\/strong><\/p>\n<p><strong>What You Will Gain<\/strong><\/p>\n<p>By completing the course, participants will:<\/p>\n<ul>\n<li>Gain a thorough understanding of EU pharmacovigilance requirements<\/li>\n<li>Improve confidence in applying GVP principles in practice<\/li>\n<li>Stay up to date with current and emerging regulatory expectations<\/li>\n<li>Strengthen their professional profile with an industry-recognized certificate<\/li>\n<\/ul>\n<p><strong>Take the Next Step<\/strong><\/p>\n<p>Advance your pharmacovigilance expertise with one of Europe\u2019s leading academic programs.<\/p>\n<ul>\n<li>Register now to secure your place<\/li>\n<li>Download the detailed program to explore the full curriculum<\/li>\n<li>Contact us for group registrations or institutional participation<\/li>\n<\/ul>\n<p><em>Join the 7th GVP Course and gain a complete, practical understanding of EU pharmacovigilance.<\/em><\/p>\n<p><strong>Frequently Asked Questions<\/strong><\/p>\n<p><strong>Is this course aligned with current EU GVP legislation?<br \/>\n<\/strong>Yes. The curriculum is fully aligned with the latest EU GVP requirements and regulatory guidance.<\/p>\n<p><strong>Is the certificate recognized by the pharmaceutical industry?<br \/>\n<\/strong>Yes. The certificate is recognized by the pharmaceutical industry and accepted as external pharmacovigilance training.<\/p>\n<p><strong>Is this course suitable for non-pharmacovigilance professionals?<br \/>\n<\/strong>Yes. Professionals from regulatory affairs, medical affairs, quality assurance, and healthcare will also benefit from the in-depth content.<\/p>\n<p><strong>Does the course include practical examples?<br \/>\n<\/strong>Yes. The program includes real-world case studies and practical insights from both regulators and industry experts.<\/p>\n<p>Essential information:<\/p>\n<ul>\n<li><strong>Organizer:\u00a0<\/strong>Semmelweis University, Department of Pharmacology and Pharmacotherapy<\/li>\n<li><strong>Accreditaion ID:<\/strong> SE-SZTOK\/2026.II\/00106<\/li>\n<li><strong>Audience:\u00a0<\/strong>pharmacovigilance professionals (entry level for general training, mid-senior level for field specific information), healthcare professionals<\/li>\n<li><strong>Date:<\/strong>\u00a017\u201318 September 2026<\/li>\n<li><strong>Language:\u00a0<\/strong>English<\/li>\n<li><strong>Fee:\u00a0<\/strong>99 500 HUF<\/li>\n<li><strong>Venue:\u00a0<\/strong>Online course via Zoom<\/li>\n<li><strong>Outcome:<\/strong>\u00a0GVP Training certificate after successful written exam<\/li>\n<\/ul>\n<p><strong>List of lectures<\/strong><\/p>\n\n<table id=\"tablepress-44\" class=\"tablepress tablepress-id-44\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\">Date<\/th><th class=\"column-2\">Appointment<\/th><th class=\"column-3\">Duration<\/th><th class=\"column-4\">Title of the presentation<\/th><th class=\"column-5\">Performer<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">8:45<\/td><td class=\"column-3\">15<\/td><td class=\"column-4\">Welcoming and introduction Learning outcome<\/td><td class=\"column-5\">Dr. M\u00e1ty\u00e1s P\u00e9terv\u00e1ri<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">9:00<\/td><td class=\"column-3\">30<\/td><td class=\"column-4\">Pharmacovigilance legislative framework, current updates<\/td><td class=\"column-5\">Dr. M\u00e1ty\u00e1s P\u00e9terv\u00e1ri<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">9:30<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">GVP Modul I - Pharmacovigilance systems - What makes a good PV system?<\/td><td class=\"column-5\">Jan Petracek<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">10:15<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">GVP Modul II - Pharmacovigilance System Master File<\/td><td class=\"column-5\">Dr. Barbara Reithauser-Ny\u00edri<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">11:15<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">GVP Modul III - Inspection<\/td><td class=\"column-5\">Hatem Adel<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">11:45<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">GVP Modul IV - Audits, and audit\/inspection preparation on local site<\/td><td class=\"column-5\">Reitthauser-Ny\u00edri Barbara<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">12:15<\/td><td class=\"column-3\">60<\/td><td class=\"column-4\">LUNCH BREAK<\/td><td class=\"column-5\"><\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">13:15<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">GVP Modul VI \u2013 Management of reports of suspected adverse reactions<\/td><td class=\"column-5\">Dr. Eszter M\u00e1tis, Nikolett L\u00e1szl\u00f3<\/td>\n<\/tr>\n<tr class=\"row-10\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">14:00<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">GVP Modul IX \u2013 Signal management<\/td><td class=\"column-5\">Enik\u0151 Pl\u00f3zer<\/td>\n<\/tr>\n<tr class=\"row-11\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">14:45<\/td><td class=\"column-3\">15<\/td><td class=\"column-4\">BREAK<\/td><td class=\"column-5\"><\/td>\n<\/tr>\n<tr class=\"row-12\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">14:45<\/td><td class=\"column-3\">30<\/td><td class=\"column-4\">GVP Modul V - Risk managementsystems<\/td><td class=\"column-5\">Enik\u0151 Pl\u00f3zer<\/td>\n<\/tr>\n<tr class=\"row-13\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">15:15<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">GVP Modul VII - Periodic safety update report<\/td><td class=\"column-5\">Vikt\u00f3ria Kis<\/td>\n<\/tr>\n<tr class=\"row-14\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">16:00<\/td><td class=\"column-3\">15<\/td><td class=\"column-4\">GVP Modul VIII - Post-authorisation safety studies and X - Additional monitoring<\/td><td class=\"column-5\">Dr. Pall\u00f3s J\u00falia<\/td>\n<\/tr>\n<tr class=\"row-15\">\n\t<td class=\"column-1\">Thursday, 17 September 2026<\/td><td class=\"column-2\">16:15<\/td><td class=\"column-3\">30<\/td><td class=\"column-4\">GVP Modul XV - Safety communication and XVI - Risk minimisation measures<\/td><td class=\"column-5\">Bal\u00e1zsa Tam\u00e1s<\/td>\n<\/tr>\n<tr class=\"row-16\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">9:00<\/td><td class=\"column-3\">30<\/td><td class=\"column-4\">Challanges of drug safety considering innovative drug development.<\/td><td class=\"column-5\">Prof. Dr. P\u00e9ter Ferdinandy<\/td>\n<\/tr>\n<tr class=\"row-17\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">9:30<\/td><td class=\"column-3\">30<\/td><td class=\"column-4\">MDR \u2013 Post-Market Safety requirements<\/td><td class=\"column-5\">Zolt\u00e1n Korm\u00e1ny<\/td>\n<\/tr>\n<tr class=\"row-18\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">10:00<\/td><td class=\"column-3\">30<\/td><td class=\"column-4\">Application of novel methods in aRMM dissemination efficiency measurments<\/td><td class=\"column-5\">Eszter Puhl<\/td>\n<\/tr>\n<tr class=\"row-19\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">10:40<\/td><td class=\"column-3\">30<\/td><td class=\"column-4\">Novel literature monitoring solutions in pharmacovigilance<\/td><td class=\"column-5\">Nicole Baker PhD<\/td>\n<\/tr>\n<tr class=\"row-20\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">11:15<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">ICSR processing - challanges and pitfalls<\/td><td class=\"column-5\">Nikolett L\u00e1szl\u00f3<\/td>\n<\/tr>\n<tr class=\"row-21\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">12:00<\/td><td class=\"column-3\">60<\/td><td class=\"column-4\">LUNCH BREAK<\/td><td class=\"column-5\"><\/td>\n<\/tr>\n<tr class=\"row-22\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">13:00<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">Engagement of HCP for pharmacovigilance<\/td><td class=\"column-5\">Dr. M\u00e1t\u00e9 \u00c1d\u00e1m Bal\u00e1zs<\/td>\n<\/tr>\n<tr class=\"row-23\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">13:45<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">Future of efficient pharmacovigilance system<\/td><td class=\"column-5\">Melissa Wood<\/td>\n<\/tr>\n<tr class=\"row-24\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">14:45<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">Vetenirary pharmacovigilance<\/td><td class=\"column-5\">Marton Szandra<\/td>\n<\/tr>\n<tr class=\"row-25\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">15:30<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">Benefit-risk assessment of medicines<\/td><td class=\"column-5\">Dr. M\u00e1t\u00e9 \u00c1d\u00e1m Bal\u00e1zs<\/td>\n<\/tr>\n<tr class=\"row-26\">\n\t<td class=\"column-1\">Friday, 18 September 2026<\/td><td class=\"column-2\">16:15<\/td><td class=\"column-3\">45<\/td><td class=\"column-4\">Course summary<\/td><td class=\"column-5\">Dr. M\u00e1ty\u00e1s P\u00e9terv\u00e1ri<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Master EU Pharmacovigilance with Confidence The 7th Good Vigilance Practice (GVP) Course organized by Semmelweis University delivers a comprehensive, practice-oriented training on European Union pharmacovigilance requirements. The program is fully aligned with current EU GVP legislation and focuses on both regulatory compliance and real-world implementation. Why This Course Matters Pharmacovigilance is a rapidly evolving regulatory &hellip;<\/p>\n","protected":false},"author":102427,"featured_media":0,"parent":974,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-fullwidth.php","meta":{"_acf_changed":false,"footnotes":""},"categories":[744],"tags":[],"class_list":["post-15504","page","type-page","status-publish","hentry","category-current-course"],"acf":[],"_links":{"self":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/15504","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/users\/102427"}],"replies":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/comments?post=15504"}],"version-history":[{"count":3,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/15504\/revisions"}],"predecessor-version":[{"id":15750,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/15504\/revisions\/15750"}],"up":[{"embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/pages\/974"}],"wp:attachment":[{"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/media?parent=15504"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/categories?post=15504"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/semmelweis.hu\/pharmacology\/wp-json\/wp\/v2\/tags?post=15504"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}