{"id":2206,"date":"2025-03-13T17:47:20","date_gmt":"2025-03-13T16:47:20","guid":{"rendered":"https:\/\/mediconomics.com\/pharmacovigilance\/"},"modified":"2025-07-15T18:47:01","modified_gmt":"2025-07-15T16:47:01","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/mediconomics.com\/en\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"2206\" class=\"elementor elementor-2206 elementor-1870\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-235ad45 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"235ad45\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-9d2b137\" data-id=\"9d2b137\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-32cbcac elementor-widget elementor-widget-image\" data-id=\"32cbcac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"303\" height=\"155\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/03\/Icon_Pharmakovigilanz_RGB_blau_2025-1.png\" class=\"attachment-full size-full wp-image-2102\" alt=\"Pharmakovigilanz\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/03\/Icon_Pharmakovigilanz_RGB_blau_2025-1.png 303w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/03\/Icon_Pharmakovigilanz_RGB_blau_2025-1-300x153.png 300w\" sizes=\"(max-width: 303px) 100vw, 303px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-df381a1\" data-id=\"df381a1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6834490 elementor-widget elementor-widget-heading\" data-id=\"6834490\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Pharmacovigilance<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-478f2df elementor-widget elementor-widget-button\" data-id=\"478f2df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"#contact\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cdc931d wellen subsite elementor-widget elementor-widget-html\" data-id=\"cdc931d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"uuid-4b071659-7ca4-4560-8197-62f6aba045f6\" data-name=\"Ebene 2\" viewbox=\"0 0 841.89 570.97\">\n  <defs>\n    <style>\n 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 <\/g>\n<\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3fc2be5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3fc2be5\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea5389a no-box-shadow-mobile\" data-id=\"ea5389a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-00a3b1a elementor-widget elementor-widget-heading\" data-id=\"00a3b1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Our pharmacovigilance services include<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d8459f elementor-widget elementor-widget-text-editor\" data-id=\"0d8459f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Evaluation of the current PV status<\/li><li>Carrying out literature research<\/li><li>Periodic Safety Update Reports (PSURs)<\/li><li>Development Safety Update Reports (DSURs)<\/li><li>EU-compliant electronic reporting (XEVPRM, ICSR)<\/li><li>Implementation of PV systems<\/li><li>Creation of risk management plans (RMPs)<\/li><li>Training, audits and more<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a8a1661 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a8a1661\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eb49e70 no-box-shadow-mobile\" data-id=\"eb49e70\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f26ca56 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f26ca56\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-4849be8\" data-id=\"4849be8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-cc72a19 elementor-widget elementor-widget-heading\" data-id=\"cc72a19\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pharmacovigilance for authorized and marketed products<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a802574 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a802574\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0889696 elementor-widget elementor-widget-heading\" data-id=\"0889696\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Continuous safety monitoring<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-118f4ea elementor-widget elementor-widget-text-editor\" data-id=\"118f4ea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The safety of medicines is our top priority. We implement robust systems for the complete recording and evaluation of adverse drug reactions (ADRs) in accordance with the requirements of Good Vigilance Practice (GVP). Our team applies advanced methods for early identification and evaluation of potential safety signals to proactively respond to potential risks. Our services include:   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3424fc elementor-widget elementor-widget-text-editor\" data-id=\"c3424fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Implementation and maintenance of pharmacovigilance databases<\/li><li>Carrying out regular signal detection analyses<\/li><li>Preparation of individual case reports (ICSRs) and follow-up reports<\/li><li>Development and implementation of risk minimization measures<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-3c52946 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3c52946\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-812b5d7\" data-id=\"812b5d7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c094daf elementor-widget elementor-widget-heading\" data-id=\"c094daf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Regulatory safety reports<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4818cf0 elementor-widget elementor-widget-text-editor\" data-id=\"4818cf0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We support you in the preparation and submission of Periodic Safety Update Reports (PSURs) in accordance with the requirements of the EMA and national authorities. In addition, we develop, update and implement risk management plans (RMPs) to proactively minimize risks. Our goal is to continuously monitor and improve the safety of your products. Our specific services include   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49e74e0 elementor-widget elementor-widget-text-editor\" data-id=\"49e74e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Creation and submission of PSURs and RMPs<\/li><li>Carrying out benefit-risk assessments<\/li><li>Updating product information (SmPC, PIL)<\/li><li>Support with the creation of red-handed letters<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-9249e65 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9249e65\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-15dac8e\" data-id=\"15dac8e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f6e19ee elementor-widget elementor-widget-heading\" data-id=\"f6e19ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Official reporting obligations<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ab35be elementor-widget elementor-widget-text-editor\" data-id=\"1ab35be\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Our experts ensure the timely submission of Individual Case Safety Reports (ICSRs) to the relevant authorities via EudraVigilance. We ensure that all regulatory requirements are met and prepare you optimally for inspections.  We offer:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b6e99f elementor-widget elementor-widget-text-editor\" data-id=\"1b6e99f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Timely reporting of ICSRs to authorities and EudraVigilance<\/li><li>Preparation and support for inspections<\/li><li>Creation and maintenance of standard operating procedures (SOPs)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6edff40 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6edff40\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-789a30a\" data-id=\"789a30a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed60dbf elementor-widget elementor-widget-heading\" data-id=\"ed60dbf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Risk communication and management<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a814f5 elementor-widget elementor-widget-text-editor\" data-id=\"4a814f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Effective communication is crucial for drug safety. We develop and implement strategies to communicate safety information to healthcare professionals and patients. In addition, we implement and monitor risk minimization measures, including the creation of educational materials for healthcare professionals and patients. Our services include:   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-643085a elementor-widget elementor-widget-text-editor\" data-id=\"643085a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Development of risk communication strategies<\/li><li>Implementation and monitoring of risk minimization measures<\/li><li>Conducting effectiveness studies for risk minimization measures<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-89406ff elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"89406ff\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-1be4255\" data-id=\"1be4255\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1b3b711 elementor-widget elementor-widget-heading\" data-id=\"1b3b711\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Quality management<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc12f99 elementor-widget elementor-widget-text-editor\" data-id=\"cc12f99\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Our robust quality management system in accordance with GVP Module I ensures the highest standards. We carry out regular internal audits and manage Corrective and Preventive Actions (CAPAs) for continuous system improvement. Our services include  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c0f451 elementor-widget elementor-widget-text-editor\" data-id=\"5c0f451\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Implementation and maintenance of quality management systems<\/li><li>Carrying out internal audits and gap analyses<\/li><li>Management of CAPAs and improvement measures<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-ce7f07b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ce7f07b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-b56f234\" data-id=\"b56f234\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e59f333 elementor-widget elementor-widget-heading\" data-id=\"e59f333\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">PSMF creation and maintenance<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f3b9bd4 elementor-widget elementor-widget-text-editor\" data-id=\"f3b9bd4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Pharmacovigilance System Master File (PSMF) is a central document. We continuously create and update your PSMF to provide a detailed description of your PV system and to be prepared for inspections.  We offer:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7df34a2 elementor-widget elementor-widget-text-editor\" data-id=\"7df34a2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Creation and continuous updating of the PSMF<\/li><li>Regular review and adaptation to regulatory changes<\/li><li>Support with the integration of new products into the PSMF<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-83d4142 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"83d4142\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-373d79a\" data-id=\"373d79a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ef22d6e elementor-widget elementor-widget-heading\" data-id=\"ef22d6e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Pharmacovigilance for clinical trials<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2dc3102 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2dc3102\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a8dd583 elementor-widget elementor-widget-heading\" data-id=\"a8dd583\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Comprehensive safety monitoring<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd32ecc elementor-widget elementor-widget-text-editor\" data-id=\"fd32ecc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>For clinical trials, we implement robust systems to seamlessly monitor adverse events throughout the duration of the trial. We develop and implement study-specific risk management plans to proactively identify and minimize potential safety risks. Our services include:  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e941191 elementor-widget elementor-widget-text-editor\" data-id=\"e941191\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Development and implementation of safety monitoring plans<\/li><li>Creation and maintenance of safety databases for clinical studies<\/li><li>Carrying out risk assessments and risk management<\/li><li>Support in the creation of test plans and declarations of consent<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-0366ece elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0366ece\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-551741b\" data-id=\"551741b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f67ae34 elementor-widget elementor-widget-heading\" data-id=\"f67ae34\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Efficient SAE and SUSAR management<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec071c9 elementor-widget elementor-widget-text-editor\" data-id=\"ec071c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Our team ensures the timely recording, evaluation and documentation of Serious Adverse Events (SAEs) in accordance with the GCP Regulation. We ensure the timely reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to authorities and ethics committees within the prescribed deadlines.  We offer:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4ea62a elementor-widget elementor-widget-text-editor\" data-id=\"c4ea62a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>24\/7 on-call service for SAE messages<\/li><li>Medical evaluation and follow-up of SAEs<\/li><li>Timely SUSAR notifications to authorities and ethics committees<\/li><li>Preparation of safety reports for investigators and sponsors<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6440fc1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6440fc1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-47c90ad\" data-id=\"47c90ad\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-57c29ee elementor-widget elementor-widget-heading\" data-id=\"57c29ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Preparation of regulatory safety reports<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43ad40a elementor-widget elementor-widget-text-editor\" data-id=\"43ad40a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We prepare comprehensive Development Safety Update Reports (DSURs) according to the ICH E2F guideline and conduct continuous benefit-risk evaluations to ensure the safety of study participants. Our services include: <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf525f9 elementor-widget elementor-widget-text-editor\" data-id=\"cf525f9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\"><li>Creation and submission of DSURs<\/li><li>Carrying out benefit-risk analyses for investigational medicinal products<\/li><li>Support in the preparation of annual reports for ethics committees<\/li><li>Updating inspector information based on safety data<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d41f9f elementor-widget elementor-widget-text-editor\" data-id=\"5d41f9f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Contact us for an individual consultation on how we can best support your specific requirements. Benefit from our expertise and concentrate on your core competencies in drug development and marketing. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-e1d33a9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e1d33a9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-c7c45e4\" data-id=\"c7c45e4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-25cbda0 elementor-widget elementor-widget-heading\" data-id=\"25cbda0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">We assume your pharmacovigilance obligations\nfor drug safety as the marketing authorization holder.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5aafeee elementor-widget elementor-widget-text-editor\" data-id=\"5aafeee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In 2012, the PV legislation was formalized and implemented by the EU to regulate the detection, management and prevention of adverse drug reactions in patients. In line with these changes and in order to comply with and implement the obligations of the PV, organizations authorized to manufacture a medicinal product for human use now require the services of a Qualified Person for Pharmacovigilance (QPPV) and, where applicable, a Stepwise Plan Representative. Mediconomics has the expertise and authorization from the European Medicines Agency (EMA) to provide your company with tailored pharmacovigilance solutions, saving you valuable time and money.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-8627813 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8627813\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-938ed00\" data-id=\"938ed00\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-80d7212 elementor-widget elementor-widget-heading\" data-id=\"80d7212\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Drug safety through constant monitoring<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f45b456 elementor-widget elementor-widget-text-editor\" data-id=\"f45b456\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The word pharmacovigilance (PV) or drug safety is composed of the Greek word pharmakon, which means &#8220;remedy&#8221; or &#8220;poison&#8221; and the Latin vigilantia &#8220;care, vigilance&#8221;.<br>Continuous and systematic monitoring of the safety of medicinal products for humans and animals results in risk minimization, which is to be achieved by assessing and understanding adverse effects and taking appropriate measures.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-aabacaa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"aabacaa\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-e671236\" data-id=\"e671236\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5ab8562 elementor-widget elementor-widget-heading\" data-id=\"5ab8562\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Compliance with legal requirements<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21d4733 elementor-widget elementor-widget-text-editor\" data-id=\"21d4733\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Despite the well-founded clinical development of a medicinal product, the monitoring and documentation of adverse events is indispensable and legally binding even after market approval. Due to the limited number of subjects in clinical trials, rare side effects and interactions can often only be detected after market launch. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-235c69a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"235c69a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-c641266\" data-id=\"c641266\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2e07919 elementor-widget elementor-widget-heading\" data-id=\"2e07919\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Patient protection is the top priority - vigilance system<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a2ba30 elementor-widget elementor-widget-text-editor\" data-id=\"6a2ba30\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Immediate reporting is mandatory at the slightest suspicion of an adverse reaction, even if a causal relationship between the medicinal product and the effect cannot be established beyond doubt. Serious rare effects are of particular interest for the overall assessment of a medicinal product. Continuous medical-scientific development can lead to new findings on safety even years after authorization. As a result, the approval status of a long-established medicinal product may have to be adapted to current scientific knowledge and, if necessary, risks and their mitigation may have to be pointed out.   <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d3076aa elementor-widget elementor-widget-text-editor\" data-id=\"d3076aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tA corresponding vigilance system exists for medical devices, the establishment of which is prescribed by European medical device legislation.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-496f2ed elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"496f2ed\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c1eb03c no-box-shadow-mobile\" data-id=\"c1eb03c\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-8c954c0 elementor-widget elementor-widget-heading\" data-id=\"8c954c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">STATEMENT OF THE DIFFERENCE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4461b73 elementor-widget elementor-widget-heading\" data-id=\"4461b73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">FROM EU-QPPV VS. STEP-BY-STEP PLAN REPRESENTATIVE ACC. \u00a7 63A AMG <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d54d1ba custom-table uael-header-sticky-no elementor-widget elementor-widget-uael-table\" data-id=\"d54d1ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"uael-table.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div itemscope class=\"uael-table-wrapper\" itemtype=\"http:\/\/schema.org\/Table\">\n\t\t<table id=\"uael-table-id-d54d1ba\" class=\"uael-text-break uael-column-rules uael-table\" data-sort-table=\"no\" data-show-entry=\"no\" data-searchable=\"no\" data-responsive=\"no\">\n\t\t\t\t<thead>\n\t\t\t\t\t\t\t\t\t\t<tr class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<th data-sort=\"0\" class=\"sort-this elementor-repeater-item-d2a039d uael-table-col uael-table-head-cell-text\" scope=\"col\">\n\t\t\t\t\t\t\t<span class=\"sort-style\">\n\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\"><\/span>\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/th>\n\t\t\t\t\t\t\t\t\t\t\t\t<th data-sort=\"1\" class=\"sort-this elementor-repeater-item-b7bb9b1 uael-table-col uael-table-head-cell-text\" scope=\"col\">\n\t\t\t\t\t\t\t<span class=\"sort-style\">\n\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">EU-QPPV<\/span>\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/th>\n\t\t\t\t\t\t\t\t\t\t\t\t<th data-sort=\"2\" class=\"sort-this elementor-repeater-item-fa2ef93 uael-table-col uael-table-head-cell-text\" scope=\"col\">\n\t\t\t\t\t\t\t<span class=\"sort-style\">\n\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Graduated plan officer (AMG)<\/span>\n\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/th>\n\t\t\t\t\t\t\t\t<\/thead>\n\t\t\t\t<tbody>\n\t\t\t<!-- ROWS -->\n\t\t\t\t\t\t\t\t\t\t<tr data-entry=\"1\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-aeb551d\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Residency<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-97b1df0\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Member State of the EU or EEA<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-5f29bac\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Member State of the EU<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"2\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-5a6e90a\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Area of responsibility<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-d95d40e\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Medical defects<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-bb647a7\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Medical and pharmaceutical\ndefects<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"3\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-dd6ff7a\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Liability<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-072826d\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Authorization holder<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-16afc19\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Personal<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"4\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-fa525df\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Penalties<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-48f9113\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">No<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-294b2a9\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Yes<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"5\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-cfbbfab\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Representation<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-d62f810\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Yes, replacement procedure and replacement person\nmust be available<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-999d3f1\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Desired<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"6\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-d7dda7c\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Contact\/Report<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-71bcb8e\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Acts as a central contact person for\ncompetent authorities of the EU member\nstates and for inspections - 24\/7\navailability required<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-d2d195c\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Obligation to report pharmaceutical risks\nand report further information at the request of the competent federal\nauthority at\n<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"7\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-ac88cdd\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">PV system<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-ced3141\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Establishment and maintenance<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-6bc673e\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">Establishment and maintenance as well as\nCollection and evaluation of drug\nrisks and coordination of necessary measures\n<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/tr><tr data-entry=\"8\" class=\"uael-table-row\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-1274c0f\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">PSMF<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-cf8cf35\" data-title=\"EU-QPPV\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">\nEnsure that the information contained in the PSMF is an accurate and\nup-to-date representation of the PV system<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<td class=\"uael-table-col uael-table-body-cell-text elementor-repeater-item-73aedf8\" data-title=\"Graduated plan officer (AMG)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"uael-table__text-inner\">No<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t\t\t\t<\/tbody>\n\t<\/table>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d1a4ff9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d1a4ff9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0eddde0\" data-id=\"0eddde0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3aa8fb7 wellen-absolute elementor-widget elementor-widget-html\" data-id=\"3aa8fb7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" id=\"Ebene_1\" data-name=\"Ebene 1\" viewbox=\"0 0 841.89 570.84\">\n  <defs>\n    <style>\n .cls-1 {\n mask: url(#mask);\n }\n\n .cls-2 {\n fill: transparent;\n stroke: #005499;\n stroke-miterlimit: 10;\n stroke-width: .32px;\n }\n\n .cls-3 {\n fill: url(#Unbenannter_Verlauf_2);\n }\n\n .cls-4 {\n filter: url(#luminosity-noclip);\n }\n\n    <\/style>\n    <filter id=\"luminosity-noclip\" x=\"-125.15\" y=\"-184.53\" width=\"1092.19\" height=\"940.03\" color-interpolation-filters=\"sRGB\" filterunits=\"userSpaceOnUse\">\n      <feflood flood-color=\"#fff\" 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 <\/g>\n<\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-a254f03 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a254f03\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-c87d89b\" data-id=\"c87d89b\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-42c176f elementor-widget elementor-widget-heading\" data-id=\"42c176f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">GENERAL OVERSIGHT<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e2d082d elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"e2d082d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\">\n \t<li>Provision of EU-QPPV and\/or Deputy<\/li>\n \t<li>PSMF creation and maintenance<\/li>\n \t<li>Support with PV integration<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-79e7645\" data-id=\"79e7645\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-af3e22c elementor-widget elementor-widget-heading\" data-id=\"af3e22c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Operational support<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-846122b elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"846122b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\">\n \t<li>Development of SOPs<\/li>\n \t<li>Conduct of PV trainings<\/li>\n \t<li>Literature research<\/li>\n \t<li>Medical assessment of ICSRs<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-d210dd1 elementor-widget__width-initial elementor-hidden-mobile elementor-widget elementor-widget-image\" data-id=\"d210dd1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"842\" height=\"430\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/05\/pv-solutions_en-1.png\" class=\"attachment-large size-large wp-image-3683\" alt=\"\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/05\/pv-solutions_en-1.png 842w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/05\/pv-solutions_en-1-300x153.png 300w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/05\/pv-solutions_en-1-768x392.png 768w\" sizes=\"(max-width: 842px) 100vw, 842px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-cddf7e4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"cddf7e4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-6275111\" data-id=\"6275111\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dee29ff elementor-widget elementor-widget-heading\" data-id=\"dee29ff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Drug safety<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9356345 elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"9356345\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\">\n \t<li>EudraVigilance registration<\/li>\n \t<li>Generation of narratives for SAEs and SUSARs<\/li>\n \t<li>Generation of Risk Management Plans<\/li>\n \t<li>Safety reports<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d3c206f\" data-id=\"d3c206f\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-096ac7c elementor-widget elementor-widget-heading\" data-id=\"096ac7c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">PV AUDITS<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-296d3fe elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"296d3fe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"dashed\">\n \t<li>Conduct of audits (vendors\/internal)<\/li>\n \t<li>Support during inspections\/audits<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d38b777 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d38b777\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-48169096 no-box-shadow-mobile\" data-id=\"48169096\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-49149377 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"49149377\" data-element_type=\"section\" data-e-type=\"section\" id=\"contact\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-6468f4f7\" data-id=\"6468f4f7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2bc8090 elementor-widget elementor-widget-image\" data-id=\"2bc8090\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/maps.app.goo.gl\/jL3EcQDvQFJALTuG7\" target=\"_blank\" rel=\"noopener\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Icon_Standort_RGB_weiss_mit_Kreis_2025.svg\" class=\"attachment-large size-large wp-image-1975\" alt=\"Standort\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Standort_RGB_weiss_mit_Kreis_2025.svg 150w, https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Standort_RGB_weiss_mit_Kreis_2025.svg 300w, https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Standort_RGB_weiss_mit_Kreis_2025.svg 1024w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ac0599d elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"7ac0599d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/maps.app.goo.gl\/jL3EcQDvQFJALTuG7\" target=\"_blank\" rel=\"noopener\">Locations<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ca1d9d9 elementor-widget elementor-widget-text-editor\" data-id=\"1ca1d9d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/maps.app.goo.gl\/jL3EcQDvQFJALTuG7\" target=\"_blank\" rel=\"noopener\">Maps<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-47322bd7\" data-id=\"47322bd7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2bfd1972 elementor-widget elementor-widget-image\" data-id=\"2bfd1972\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"mailto:contact@mediconomics.com\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Icon_Email_RGB_weiss_mit_Kreis_2025.svg\" class=\"attachment-large size-large wp-image-1976\" alt=\"Email\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Email_RGB_weiss_mit_Kreis_2025.svg 150w, https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Email_RGB_weiss_mit_Kreis_2025.svg 300w, https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Email_RGB_weiss_mit_Kreis_2025.svg 1024w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e545847 elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"5e545847\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"mailto:contact@mediconomics.com\" target=\"_blank\" rel=\"noopener\">contact@mediconomics.com<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7b854cdb elementor-widget elementor-widget-text-editor\" data-id=\"7b854cdb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"mailto:contact@mediconomics.com\">Email<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-15c5472e\" data-id=\"15c5472e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-56c6a276 elementor-widget elementor-widget-image\" data-id=\"56c6a276\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"tel:+495115609980\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Icon_Telefon_RGB_weiss_mit_Kreis_2025.svg\" class=\"attachment-large size-large wp-image-1977\" alt=\"Telefon\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Telefon_RGB_weiss_mit_Kreis_2025.svg 150w, https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Telefon_RGB_weiss_mit_Kreis_2025.svg 300w, https:\/\/mediconomics.com\/wp-content\/uploads\/\/2025\/02\/Icon_Telefon_RGB_weiss_mit_Kreis_2025.svg 1024w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3263066b elementor-hidden-mobile elementor-widget elementor-widget-text-editor\" data-id=\"3263066b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"tel:+495115609980\">+49 (0) 511 560 998-0<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17d06fd8 elementor-widget elementor-widget-text-editor\" data-id=\"17d06fd8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"tel:+495115609980\">Call us<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-42252d3a elementor-widget elementor-widget-heading\" data-id=\"42252d3a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">And what can we do for you?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div 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value=\"27\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/2206\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-27\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Send\" aria-live=\"assertive\" value=\"wpforms-submit\">Send<\/button><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/mediconomics.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container --><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7de6f4f columns-mobile-and-tablet elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7de6f4f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-2d1b12b\" data-id=\"2d1b12b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-46e6922 image-br elementor-widget elementor-widget-image\" data-id=\"46e6922\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"833\" height=\"1024\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-833x1024.jpg\" class=\"attachment-large size-large wp-image-1982\" alt=\"Uwe_Albrecht\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-833x1024.jpg 833w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-244x300.jpg 244w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-768x944.jpg 768w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025-1250x1536.jpg 1250w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Uwe_Albrecht_2025.jpg 1512w\" sizes=\"(max-width: 833px) 100vw, 833px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fa8b492 elementor-widget elementor-widget-text-editor\" data-id=\"fa8b492\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Dr. (MD) Uwe Albrecht,<br>FIBMS, FFPM (Dis.), FICR, CSci<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5cf14dc elementor-widget elementor-widget-text-editor\" data-id=\"5cf14dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>CEO<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-88b50ac\" data-id=\"88b50ac\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ba21947 image-br elementor-widget elementor-widget-image\" data-id=\"ba21947\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"605\" src=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1024x605.jpg\" class=\"attachment-large size-large wp-image-1983\" alt=\"Hauptsitz_Mediconomics\" srcset=\"https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1024x605.jpg 1024w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-300x177.jpg 300w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-768x454.jpg 768w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025-1536x907.jpg 1536w, https:\/\/mediconomics.com\/wp-content\/uploads\/2025\/02\/Bild_Hauptsitz_Mediconomics_2025.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2da432 elementor-widget elementor-widget-text-editor\" data-id=\"a2da432\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Headquarters<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b1a2a6 elementor-widget elementor-widget-text-editor\" data-id=\"2b1a2a6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Hanover<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-bc5f915 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bc5f915\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e8e7f7d\" data-id=\"e8e7f7d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3ed630d elementor-widget elementor-widget-heading\" data-id=\"3ed630d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><b>FAQ<\/b> \u2013 frequently asked questions<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-40a09d9 elementor-widget elementor-widget-html\" data-id=\"40a09d9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\nWhat is pharmacovigilance in practice?\n    <\/div>\n    <div class=\"dropdown-content\">\nAll activities associated with monitoring the safety of medicinal products with the aim of detecting adverse effects and subsequently taking measures to minimize risks fall under this area.<br>\nThe most important tasks in practice are the continuous monitoring of the risks in relation to the benefits of a medicinal product after authorization and the assessment of incoming suspected cases of adverse reactions after authorization and after market launch.<br>\nPV is used for risk management relating to the use of medicinal products, the detection of production errors or defective packaging, the prevention of therapeutic errors and the communication of information on medicinal products. Furthermore, the reporting of adverse drug reactions to the competent authorities is an important element of PV. <br>\nIn the field of medical devices, there is also the concept of vigilance - formalized by the MDR - which deals with product safety from the start of marketing.\n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04ceb9a elementor-widget elementor-widget-html\" data-id=\"04ceb9a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\nWho needs support in the area of pharmacovigilance?\n    <\/div>\n    <div class=\"dropdown-content\">\nA sponsor or marketing authorization holder can commission a contract research organization (CRO) to take on the corresponding obligations for the duration of a clinical trial to test a medicinal product or for the period after approval and market launch.\n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8244b88 elementor-widget elementor-widget-html\" data-id=\"8244b88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\nWho offers professional support in the area of pharmacovigilance?\n    <\/div>\n    <div class=\"dropdown-content\">\nContract research organizations (CROs) as service providers in the medical field, such as Mediconomics, offer professional support in this area. For example, experts take over the development and maintenance of the PV master data or the risk management plan, prepare safety reports, handle the legally compliant processing and submission of safety reports on individual cases in the form of ICSRs or carry out audits and training. In addition, the companies can provide certain persons who must have precisely defined qualifications, such as the level plan officer.  \n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d0c3e2 elementor-widget elementor-widget-html\" data-id=\"2d0c3e2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\nWhy should I outsource pharmacovigilance activities?\n    <\/div>\n    <div class=\"dropdown-content\">\nOutsourcing PV activities offers numerous benefits, including cost efficiencies, access to specialized expertise and technology, and the ability to focus on your core competencies. By working with an experienced service provider like Mediconomics, you can ensure that all regulatory requirements are met while optimizing internal resources. \n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4cfd505 elementor-widget elementor-widget-html\" data-id=\"4cfd505\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\nHow do you ensure data security and confidentiality when handling sensitive patient data?\n    <\/div>\n    <div class=\"dropdown-content\">\nData security and confidentiality are our top priorities. We use state-of-the-art security measures, including encryption, access controls and regular security audits. Our systems and processes are fully GDPR compliant and we regularly train our staff on data security.  \n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c80018d elementor-widget elementor-widget-html\" data-id=\"c80018d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\nHow do you integrate your services into our existing processes and systems?\n    <\/div>\n    <div class=\"dropdown-content\">\nWe work closely with you to seamlessly integrate our services into your existing processes and systems. This includes customizing our systems to your requirements, training your staff and providing ongoing communication to ensure that all activities run smoothly and efficiently. \n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9effc92 elementor-widget elementor-widget-html\" data-id=\"9effc92\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"custom-dropdown\">\n    <div class=\"dropdown-header\">\nHow do you deal with international differences in reporting deadlines and requirements?\n    <\/div>\n    <div class=\"dropdown-content\">\nOur team is very familiar with the international differences in reporting deadlines and requirements. We have established processes to ensure that all reports are submitted on time and in accordance with the respective national regulations. Our international reach and local expertise enable us to efficiently meet the requirements in different countries.  \n\n    <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Pharmacovigilance Contact us Our pharmacovigilance services include Evaluation of the current PV status Carrying out literature research Periodic Safety Update Reports (PSURs) Development Safety Update Reports (DSURs) EU-compliant electronic reporting (XEVPRM, ICSR) Implementation of PV systems Creation of risk management plans (RMPs) Training, audits and more Pharmacovigilance for authorized and marketed products Continuous safety monitoring [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-2206","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/2206","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/comments?post=2206"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/pages\/2206\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=2206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}