{"id":8161,"date":"2021-11-12T10:43:20","date_gmt":"2021-11-12T08:43:20","guid":{"rendered":"https:\/\/medfilesgroup.com\/our-services\/pharmacovigilance-vigilance-service%e2%80%8b\/human-and-veterinary-medicinal-products-post-marketing-pharmacovigilance\/"},"modified":"2026-07-24T11:58:51","modified_gmt":"2026-07-24T08:58:51","slug":"human-post-authorisation-pharmacovigilance","status":"publish","type":"page","link":"https:\/\/medfilesgroup.com\/ja\/our-services\/pharmacovigilance-vigilance-service\/human-post-authorisation-pharmacovigilance\/","title":{"rendered":"Post-authorisation pharmacovigilance services for human medicinal products"},"content":{"rendered":"\n<figure class=\"wp-block-image alignfull size-full\"><img width=\"1920\" height=\"554\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/post-authorisation-pharmacovigilance-services-for-human-medicinal-products.jpg\" alt=\"\" class=\"wp-image-19035\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/post-authorisation-pharmacovigilance-services-for-human-medicinal-products.jpg 1920w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/post-authorisation-pharmacovigilance-services-for-human-medicinal-products-300x87.jpg 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/post-authorisation-pharmacovigilance-services-for-human-medicinal-products-1024x295.jpg 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/post-authorisation-pharmacovigilance-services-for-human-medicinal-products-768x222.jpg 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/post-authorisation-pharmacovigilance-services-for-human-medicinal-products-1536x443.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n<div class=\"wp-block-group alignfull\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n\n\n\n<h1 class=\"wp-block-heading\">Post-authorisation pharmacovigilance services for human medicinal products<\/h1>\n\n\n\n<p>Medfiles provides pharmacovigilance services for human medicinal products <strong>in the EU, the UK and the US<\/strong>. With over 20 years\u2019 experience in pharmacovigilance, our team will help you to meet your obligations efficiently and in line with regulatory expectations. We offer both fully outsourced solutions and flexible support tailored to your needs.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for more information or an offer<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/shorturl.at\/Xqzej\" style=\"font-size:15px\" rel=\"noopener\">Book a meeting<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:42px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color has-link-color wp-elements-7572b7ced447ac07c34f7ff76eeb260c\">Read about human post-authorisation pharmacovigilance services<\/h2>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">PV system set-up and maintenance<\/h2>\n\n\n\n<p>With Medfiles experienced pharmacovigilance team we can set up your pharmacovigilance system or improve your existing system, our experienced team is here to support you. <\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>Medfiles will find the right solutions for your company and your product\u2019s safety profile, in line with the current pharmacovigilance requirements. We will help you determine the necessary internal and external communication channels and responsibilities of stakeholders related to your product and patient safety.<\/p>\n\n\n\n<p>Medfiles can create and maintain your pharmacovigilance system master file (PSMF) and ensure that your PV system remains fully compliant with the applicable European and US regulations and guidelines, to be inspection-ready at all times.<\/p>\n\n\n\n<p>Medfiles has its own full PV and quality system in place: if you need to create a pharmacovigilance system or improve your existing system, we can prepare and review your standard operating procedures (SOPs) and other quality-controlled operating instructions needed for the process. With our extensive experience, we are ready to build your system for human medicinal products and herbal medicines.<\/p>\n\n\n\n<p>Medfiles can provide a customisable and automated document management system, letting you focus on your direct responsibilities. With our system, you can manage your documents and their processes with the highest possible efficiency and security.<\/p>\n\n\n\n<div style=\"height:1px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:10px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Local pharmacovigilance activities<\/h2>\n\n\n\n<p id=\"case\">Medfiles\u2019 dedicated and experienced team provides local QPPV and contact person services with in-house resources and expertise, combined with local safety teams.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>Local services include<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Local contact person<\/li>\n\n\n\n<li>ICSR intake and local case processing<\/li>\n\n\n\n<li>Local literature reviews<\/li>\n\n\n\n<li>Local submissions (such as aggregate reports, RMPs and ICSRs)<\/li>\n\n\n\n<li>Compliance monitoring<\/li>\n\n\n\n<li>Translations and modifications of aRMMs according to local regulations, and aRMM submissions<\/li>\n\n\n\n<li>Local PV intelligence<\/li>\n\n\n\n<li>Fulfilling local PV requirements in relevant procedures and systems<\/li>\n\n\n\n<li>PV training<\/li>\n\n\n\n<li>Regulatory authority inspections<\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/services\/pharmacovigilance-services\/human-post-authorisation-pharmacovigilance\/#medical-information\">Medical information services<\/a><\/li>\n\n\n\n<li>Translations<\/li>\n<\/ul>\n\n\n\n<p><strong>See also:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/medfilesgroup.com\/storage-conditions-for-pharmaceuticals-2\/\">QPPV, local QPPV and named safety contact<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/medfiles-link-medical-partners-northern-europe\/\">Medfiles and LINK Medical: partners in local regulatory and pharmacovigilance services<\/a><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--2\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Literature and social media screening<\/h2>\n\n\n\n<p>Literature monitoring is a key element of any pharmacovigilance system. Medfiles can manage your global and local literature screening as well as monitor the EMA\u2019s Medical Literature Monitoring (MLM) service, complete with text review and assessment of safety information.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>Our search is not only limited to identifying individual case safety reports, but also includes detection of potential safety issues. Each search includes evaluating the significance of the hit concerning periodic safety reports. Literature screening supports your signal management process, including development and management of the benefit-risk profile of your product.<\/p>\n\n\n\n<p>Company social media sites require screening by the marketing authorisation holder. Medfiles can assist you in following the relevant discussions on social media.<\/p>\n\n\n\n<div style=\"height:1px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--3\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:10px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">ICSR case processing and safety database<\/h2>\n\n\n\n<p>Medfiles can provide clinical trial and post-authorisation case processing. Our EU-based experts will perform triage, data entry, MedDRA\/WHODrug coding, narrative writing, medical evaluation and expedited reporting of ICSRs. We can process your PV system reports for the EU\/EEA, the US, Canada and the UK.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p><\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img width=\"1920\" height=\"820\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-intake-2.png\" alt=\"ICSR intake\" class=\"wp-image-17737\" style=\"width:749px;height:auto\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-intake-2.png 1920w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-intake-2-300x128.png 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-intake-2-1024x437.png 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-intake-2-768x328.png 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-intake-2-1536x656.png 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n\n\n<p>Our case processing activities are always tailored to your needs, from receiving and forwarding reports to complete case processing, including submissions to the competent authorities.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img width=\"3310\" height=\"1315\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-services-2.png\" alt=\"\" class=\"wp-image-17727\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-services-2.png 3310w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-services-2-300x119.png 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-services-2-1024x407.png 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-services-2-768x305.png 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-services-2-1536x610.png 1536w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/09\/icsr-services-2-2048x814.png 2048w\" sizes=\"(max-width: 3310px) 100vw, 3310px\" \/><\/figure>\n\n\n\n<p>Our service portfolio includes a validated cloud-based safety database PV 24\/7 and the services of in-house safety physicians. Our Pharmacovigilance Data Management Team can provide cost-effective solutions to manage and process your ICSRs. Medfiles can provide safety management of your post-authorisation studies, including full case processing, signal detection and cumulative safety analysis.<\/p>\n\n\n<div class=\"gb-container gb-container-a907fd01\">\n\n<p><strong>Benefits of the PV 24\/7 database:<\/strong><\/p>\n\n<\/div>\n\n\n<ul class=\"wp-block-list\">\n<li>Continuously up to date with the latest regulatory requirements<\/li>\n\n\n\n<li>Direct gateway connections for EMA and FDA submissions<\/li>\n\n\n\n<li>Powerful real-time reporting and dashboards<\/li>\n\n\n\n<li>ICH E2B (R3) structure alignment<\/li>\n\n\n\n<li>Secure, compliant and validated in accordance with FDA 21 CFR Part 11 Electronic Records, Electronic Signatures and EudraLex Annex 11: Computerised Systems<\/li>\n<\/ul>\n\n\n\n<p><strong>See also:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/medfilesgroup.com\/eu-qppv-ensures-drug-safety-across-europe\/\"><\/a><a href=\"https:\/\/medfilesgroup.com\/safety-database-case-processing\/\">A safety database is a fundamental element of case processing<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/outsourcing-icsr-processing-pharmacovigilance\/\">Outsourcing ICSR processing &#8211; benefits and considerations<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/medfilesgroup.com\/icsr-project-leader-efficient-case-processing\/\">ICSR Project Leader responsible for case processing<\/a><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--4\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Product information update in XEVMPD and EudraVigilance set-up, maintenance and registration<\/h2>\n\n\n\n<p>Pharmaceutical companies holding or applying for a marketing authorisation and sponsors of clinical trials in the EEA must be registered in the EudraVigilance system. <\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>Medfiles can create your EudraVigilance account, update your organisation\u2019s data as needed, create and manage your affiliates and virtual affiliates and manage your EudraVigilance users. Medfiles can guide you through the EudraVigilance set-up process.<\/p>\n\n\n\n<p>Our experts can manage your EudraVigilance obligations and submit adverse event reports to regulatory authorities. Our team follows any system changes and updates to the EudraVigilance.<\/p>\n\n\n\n<p>MAHs and MA applicants for medicinal products in the EU must submit information on authorised medicines to the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), also known as the Article 57 database, and keep this information up to date. In addition, every MAH and applicant must keep its organisation details, EU QPPV details and location of the PSMF updated in the xEVMPD. Withour experts, xEVMPD will beup-to-date and fully compliant. <\/p>\n\n\n\n<p>Our team will conduct several quality checks during the creation of product report messages (XEVPRM) for submission to the XEVMPD and keep you informed of successful submissions. Maintenance of the XEVMPD requires close communication, especially with the regulatory team, to ensure timely updating of the submitted information.<\/p>\n\n\n\n<div style=\"height:1px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--5\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:10px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Signal management<\/h2>\n\n\n\n<p>For continuous and periodic signal detection and management, Medfiles has in place robust procedures in accordance with GVP Module IX: Signal management and FDA\u2019s Guidance on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>Our experienced team with safety physicians continuously reviews existing data to detect and subsequently evaluate safety signals from various sources, including the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Global safety database listings and tabulations<\/li>\n\n\n\n<li>Information from literature screening (such as class effects and potential drug interactions)<\/li>\n\n\n\n<li>Emerging pre-clinical findings (such as teratogenic analyses and effects on pregnancy)<\/li>\n\n\n\n<li>Blinded\/open label clinical data (such as Data and Safety Monitoring Board (DSMB) summaries and clinical study reports)<\/li>\n\n\n\n<li>Regulatory agency information (such as Pharmacovigilance Risk Assessment Committee (PRAC) findings and FDA notices)<\/li>\n\n\n\n<li>Information from partners<\/li>\n\n\n\n<li>EudraVigilance Data Analysis System (EVDAS), FDA Adverse Event Reporting System (FAERS) and information available from other regulatory databases<\/li>\n\n\n\n<li>Competitor product information.<\/li>\n<\/ul>\n\n\n\n<p>When needed, Medfiles can arrange safety review meetings with key stakeholders from the MAH\u2019s organisation to discuss these safety findings and decide the appropriate actions.<\/p>\n\n\n\n<p><strong>See also:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/medfilesgroup.com\/signal-management\/\">Blog: Are we really performing signal management &#8211; or just think we are doing it?<\/a><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--6\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Aggregate safety reports<\/h2>\n\n\n\n<p>Let us ensure continuous monitoring of your medicinal products\u2019 safety profile. We can handle your aggregate safety reporting obligations throughout the product lifecycle, from development to market, by writing:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Addendums to the Clinical Overviews (ACOs).<\/li>\n\n\n\n<li>Development Safety Update Reports (<a href=\"https:\/\/medfilesgroup.com\/services\/pharmacovigilance-services\/clinical-trials-safety\/\">DSURs<\/a>)<\/li>\n\n\n\n<li>Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs) and Periodic Benefit-Risk Evaluation Reports (PBRERs)<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>With our comprehensive experience, including writing over 300 PSURs and PADERs, Medfiles can prepare all line listings, frequency tabulations and trend reports, as required, or propose additional solutions and customisable reports according to your needs.<\/p>\n\n\n\n<p>We continuously follow the changes in legislation and ensure that submissions are always compliant and done according to the regulatory timelines.<\/p>\n\n\n\n<div style=\"height:1px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--7\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:10px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Risk management and risk minimisation activities<\/h2>\n\n\n\n<p>The risk management plan (RMP) describes the risk management system and contains information about identified risks, potential risks and missing information regarding a medicinal product. It outlines any risk minimisation measures adopted and includes information about monitoring the effectiveness of these measures. An effective risk management system is a critical part of pharmacovigilance and patient safety.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>All new applications for medicinal products within the European Union and UK require submission of a RMP to the European Medicines Agency (EMA) or the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom.<\/p>\n\n\n\n<p>The United States Food and Drug Administration (FDA) may request a risk evaluation and mitigation strategy (REMS) which is essentially a risk management plan that includes one or more elements aiming to ensure that the benefits of a drug outweigh its risks. Risk management is a key factor in FDA\u2019s risk-benefit assessment. As a whole, risk management consists of both risk assessment and risk minimisation: it is an iterative process involving assessing a drug\u2019s benefit-risk balance, developing and implementing tools to minimise the drug\u2019s risks while preserving its benefits, evaluating tool effectiveness and reassessing the benefit-risk balance, and making adjustments, as appropriate, to the risk minimisation tools to further improve the benefit-risk balance.<\/p>\n\n\n\n<p>To ensure compliance and improve patient safety, Medfiles\u2019 risk management experts and safety physicians can identify new safety concerns and propose appropriate and effective risk minimisation measures for your products on your behalf.<\/p>\n\n\n\n<p>In cooperation with the marketing authorisation holder, our experts write and submit product-specific risk management plans, risk evaluations and REMSs to the competent authorities at the time of marketing authorisation application or whenever relevant information is updated. We will keep your RMPs and REMSs up to date with the applicable requirements and information collected about the product.<\/p>\n\n\n\n<p>Our experts can plan the additional risk minimisation measures, their implementation and evaluation of their effectiveness for you. With its extensive regulatory and pharmacovigilance network, Medfiles can efficiently modify your documents according to the local regulatory requirements.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--8\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Pharmacovigilance agreements (PVA)<\/h2>\n\n\n\n<p>Marketing authorisation holders (MAHs) may outsource or delegate any activities related to distribution, marketing, sales or pharmacovigilance to another party. In such cases and if there is any chance of receiving new safety information, a pharmacovigilance agreement (PVA) must be in place. The PVA indicates the pharmacovigilance responsibilities of each party. When you need help in allocating the right responsibilities to the responsible parties, Medfiles can help.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>A safety data exchange agreement is a legal written agreement that requires different stakeholders (such as manufacturers, distributors and partners) to exchange all safety data for medicinal products with marketing authorisation holders. The MAH must therefore clarify the applicable responsibilities in the agreement to ensure that the European Qualified Person for Pharmacovigilance will be kept up to date with all safety issues and emerging safety concerns in real time.<\/p>\n\n\n\n<p>With our extensive experience in creating pharmacovigilance agreements and safety data exchange agreements, we can draft your agreements with the relevant business partners (such as associated manufacturers, marketing partners, distribution networks or vendors) with responsibilities, communication channels and methods for the exchange of safety information clearly established.<\/p>\n\n\n\n<div style=\"height:1px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--9\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:10px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Post-authorisation safety studies (PASS)<\/h2>\n\n\n\n<p>PASS is an important tool to actively evaluate safety concerns in the real-world setting. A study is classified as a PASS when the main aim for initiating the study is to<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>quantify potential or identified risks<\/li>\n\n\n\n<li>evaluate the risks of a medicinal product used by a patient population for which safety information is limited or missing<\/li>\n\n\n\n<li>evaluate the risks of a medicinal product after long-term use<\/li>\n\n\n\n<li>provide evidence about the absence of risks, assess patterns of drug utilisation that add knowledge regarding the safety of the medicinal product or the effectiveness of an RMP.<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>A PASS can be a clinical trial or a non-interventional study.<\/p>\n\n\n\n<p>When you are planning a PASS, the Medfiles pharmacovigilance experts and <a href=\"https:\/\/medfilesgroup.com\/services\/clinical-services\/\">the Medfiles Clinical Team<\/a> can help you with both clinical and non-interventional studies, including the set-up, management and design of the PASS as well as writing the study protocol, progress report and final study report.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--10\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Safety phycisians<\/h2>\n\n\n\n<p>Our experienced drug safety physicians can assist your drug safety unit in assessing ICSRs as well as in signal and benefit-risk management documentation, risk management plans, emerging safety concerns and any other information relating to the benefit-risk evaluation of your medicinal products. The Medfiles safety physicians are well trained on the applicable pharmacovigilance regulations, good pharmacovigilance practices (GVP) and the MedDRA coding.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:10px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Pharmacovigilance audits<\/h2>\n\n\n\n<p id=\"medical-information\">Pharmacovigilance (PV) audits are designed to verify the appropriateness and effectiveness of the implementation and operation of a PV system, including its quality system. Medfiles has dedicated and knowledgeable auditors to conduct audits that meet the European pharmacovigilance requirements.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>Our audits cover the entire PV system, including case intake, adverse event processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management and clinical safety. Audits of your affiliates, license partners, service providers and distributors, as well as due diligence audits, can be included in our PV audit service.<\/p>\n\n\n\n<p>Implementing a risk-based approach to PV audits and creating the right audit strategy, effective audit program and robust CAPA management system with Medfiles results in a fully functional, high-quality PV system that complies with GVP Modules I, III and IV.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--11\"><a class=\"wp-block-button__link has-darker-blue-color has-white-background-color has-text-color has-background has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group has-background\" style=\"background-color:#78bbd8\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:27%\">\n<figure class=\"wp-block-image size-large\"><img width=\"1024\" height=\"1024\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2022\/03\/medical-information-service-1024x1024.jpg\" alt=\"medical information service\" class=\"wp-image-19968\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2022\/03\/medical-information-service-1024x1024.jpg 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2022\/03\/medical-information-service-300x300.jpg 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2022\/03\/medical-information-service-150x150.jpg 150w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2022\/03\/medical-information-service-768x768.jpg 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2022\/03\/medical-information-service-360x360.jpg 360w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2022\/03\/medical-information-service.jpg 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading has-darker-blue-color has-text-color\" style=\"font-size:22px\">Medical information services in the EU<\/h2>\n\n\n\n<p>If you need an expert medical information team to handle your company&#8217;s medical information services in Europe, Medfiles is here to help. Our services cover both pharmaceuticals and medical devices and are fully compliant with national and EU legislation. We will help your company set up, maintain and develop the required functions. Close cooperation and open communication ensure a smooth workflow and efficient processes.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:15px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p>Ongoing quality control activities are part of our processes. By outsourcing your company&#8217;s pharmaceutical information functions to Medfiles, you will have access to a resource-saving high-quality service solution tailored to your needs.<\/p>\n\n\n\n<p>Our service-minded and patient safety-oriented team ensures that all inquiries are answered promptly and that responses are based on accurate and up-to-date product information.<\/p>\n\n\n\n<p><strong>Medfiles\u2019 medical information services include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Telephone and email services<\/li>\n\n\n\n<li>Professional customer service<\/li>\n\n\n\n<li>Immediate responses to questions<\/li>\n\n\n\n<li>Forwarding questions without intermediaries to company-designated contacts<\/li>\n\n\n\n<li>Processing adverse reaction reports and forwarding them to your pharmacovigilance unit<\/li>\n\n\n\n<li>Forwarding product defects and product complaints to your quality assurance unit<\/li>\n\n\n\n<li>Monitoring of reporting timelines<\/li>\n\n\n\n<li>Acting as an effective and proactive link between your company and healthcare staff or patients<\/li>\n\n\n\n<li>Translation services<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"#contact-us\" style=\"font-size:15px\">Ask for an offer<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:59px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfilesgroup.com\/services\/pharmacovigilance-vigilance-service\/\" style=\"font-size:15px\">Read about our other pharmacovigilance services <\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfilesgroup.com\/ja\/our-services\/regulatory-affairs-of-human-and-veterinary-medicines\/regulatory-affairs-services-2\/#main\/#main\" style=\"font-size:15px\">Regulatory affairs services<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfilesgroup.com\/ja\/our-services\/clinical-services\/\" style=\"font-size:15px\">Clinical trial services<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:59px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-cover is-light has-parallax\"><div class=\"wp-block-cover__image-background wp-image-19105 has-parallax\" style=\"background-position:50% 50%;background-image:url(https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/medfiles-graphic.jpg)\"><\/div><span aria-hidden=\"true\" class=\"wp-block-cover__background has-white-background-color has-background-dim-30 has-background-dim\"><\/span><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" style=\"font-size:27px\">Over 20 years of experience in pharmacovigilance<\/h2>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" style=\"font-size:25px\"><strong>90+<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-center has-darker-blue-color has-text-color\" style=\"text-transform:uppercase\">clients in 20 countries (eu, usa, asia)<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" style=\"font-size:25px\"><strong>6000+<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-center has-darker-blue-color has-text-color\" style=\"text-transform:uppercase\">Medicinal products monitored<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" style=\"font-size:25px\"><strong>4000+<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-center has-darker-blue-color has-text-color\" style=\"text-transform:uppercase\">Medical enquiries<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" style=\"font-size:25px\"><strong>150+<\/strong><\/h2>\n\n\n\n<p class=\"has-text-align-center has-darker-blue-color has-text-color\" style=\"text-transform:uppercase\">Aggregate reports<\/p>\n<\/div>\n<\/div>\n\n\n\n<p class=\"has-text-align-center\" style=\"font-size:12px\">*Figures include both human and veterinary experience<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-cover is-light has-parallax\"><div class=\"wp-block-cover__image-background wp-image-19105 has-parallax\" style=\"background-position:50% 50%;background-image:url(https:\/\/medfilesgroup.com\/wp-content\/uploads\/2025\/04\/medfiles-graphic.jpg)\"><\/div><span aria-hidden=\"true\" class=\"wp-block-cover__background has-white-background-color has-background-dim-30 has-background-dim\"><\/span><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-text-align-left has-darker-blue-color has-text-color has-link-color wp-elements-fc99c10699b0bfef4ae8a8295dd336c2\" style=\"font-size:24px\"><strong>News and<\/strong> <strong>insights on pharmacovigilance<\/strong><\/h2>\n\n\n\n<p>Our expert team regularly writes blogs on human medicine pharmacovigilance, covering topics such as Regulation 2025\/1466, ICSR case processing and EU QPPV.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfilesgroup.com\/service\/pharmacovigilance-human-medicines\/\" style=\"font-size:15px\">See all publications<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfilesgroup.com\/contact-us\/subscribe-newsletter\/\" style=\"font-size:15px\">Subscribe to medfiles&#8217; newsletter<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color has-link-color wp-elements-7fda3874d799f09ec6d0ef43dd6361e3\" style=\"font-size:28px\">Pharmacovigilance team leaders<\/h2>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:200px\">\n<figure class=\"wp-block-image size-full\"><img width=\"600\" height=\"900\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2026\/05\/satu-kujala.jpg\" alt=\"\" class=\"wp-image-22764\" style=\"object-fit:cover\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2026\/05\/satu-kujala.jpg 600w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2026\/05\/satu-kujala-200x300.jpg 200w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><strong>Satu Kujala<\/strong><br\/>Head of Pharmacovigilance<\/p>\n\n\n\n<p class=\"has-small-font-size\">Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p class=\"has-small-font-size\">Satu has a Licentiate\u2019s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.<\/p>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:200px\">\n<figure class=\"wp-block-image size-full\"><img width=\"600\" height=\"900\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/saara-mikkola.jpg\" alt=\"\" class=\"wp-image-16884\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/saara-mikkola.jpg 600w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2024\/04\/saara-mikkola-200x300.jpg 200w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><strong>Saara Mikkola<br\/><\/strong>Head of Operations, Pharmacovigilance, EU QPPV<\/p>\n\n\n\n<p class=\"has-small-font-size\">Saara Mikkola joined Medfiles Pharmacovigilance team in 2020 as a Drug Safety Expert, and in 2022 she was promoted to Safety Manager and later to Head of Operations, Pharmacovigilance. She works as an EU QPPV for Medfiles and has her focus on post-market pharmacovigilance services.<\/p>\n\n\n\n<div class=\"wp-block-buttons read-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read more<\/a><\/div>\n<\/div>\n\n\n\n<p class=\"has-small-font-size\">Saara has a master\u2019s degree in pharmacy and graduated from the University of Helsinki, Finland, in 2012. She has worked within the pharmaceutical industry for over 10 years with her focus on pharmacovigilance. Saara has gained her expertise through diverse pharmacovigilance tasks and responsibilities. She is well-versed in the operational aspects of pharmacovigilance, including case processing, quality management, compliance with regulatory requirements (EU regulation), and maintaining pharmacovigilance systems.<\/p>\n\n\n\n<p class=\"has-small-font-size\">She is adept at working in cross-functional teams, collaborating with different stakeholders, and adapting to the ever-evolving pharmacovigilance landscape and technologies.<\/p>\n\n\n\n<div class=\"wp-block-buttons hide-more is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" style=\"font-size:13px\">Read less<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<script src=\"https:\/\/medfiles.activehosted.com\/f\/embed.php?id=17\" charset=\"utf-8\"><\/script>\n\n\n\n<div class=\"wp-block-group has-white-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-wide\" style=\"background-color:#ecececc2;color:#ecececc2\"\/>\n\n\n\n<h2 class=\"wp-block-heading has-text-align-center has-darker-blue-color has-text-color\" id=\"contact-us\">for more information please contact<\/h2>\n\n\n\n<div style=\"height:29px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:200px\"><div class=\"wp-block-image is-style-default\">\n<figure class=\"alignleft size-full\"><img width=\"600\" height=\"900\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/reini-mervi.jpg\" alt=\"Mervi Reini\" class=\"wp-image-13749\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/reini-mervi.jpg 600w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/08\/reini-mervi-200x300.jpg 200w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/figure>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:370px\">\n<p class=\"has-text-align-left\"><strong>Mervi Reini<\/strong><br\/>Marketing Manager<br\/>+358 20 744 1502<br\/><a href=\"mailto:mervi.reini@medfiles.eu\">mervi.reini@medfiles.eu<\/a>  <\/p>\n\n\n\n<p class=\"has-text-align-left\">\ud83d\udcc5 <a href=\"https:\/\/shorturl.at\/Xqzej\" rel=\"noopener\">Book a free 30-minute meeting with the team<\/a><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-text-color has-alpha-channel-opacity has-background is-style-default\" 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12 experts ensures high-quality regulatory services in the Baltic countries<\/a><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/medfilesgroup.com\/contact-us\/subscribe-newsletter\/\">Subscribe to Medfiles&#8217; newsletter<\/a><\/div>\n<\/div>\n\n<\/div><\/div><\/div>\n<\/div>\n<\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Post-authorisation pharma &#8230; <a title=\"Post-authorisation pharmacovigilance services for human medicinal products\" class=\"read-more\" href=\"https:\/\/medfilesgroup.com\/ja\/our-services\/pharmacovigilance-vigilance-service\/human-post-authorisation-pharmacovigilance\/\" aria-label=\"More on Post-authorisation pharmacovigilance services for human medicinal products\">Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":19041,"parent":6470,"menu_order":13,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-8161","page","type-page","status-publish","has-post-thumbnail"],"_links":{"self":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/pages\/8161","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/comments?post=8161"}],"version-history":[{"count":58,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/pages\/8161\/revisions"}],"predecessor-version":[{"id":23354,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/pages\/8161\/revisions\/23354"}],"up":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/pages\/6470"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/media\/19041"}],"wp:attachment":[{"href":"https:\/\/medfilesgroup.com\/ja\/wp-json\/wp\/v2\/media?parent=8161"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}