{"id":48955,"date":"2023-05-15T06:30:31","date_gmt":"2023-05-15T06:30:31","guid":{"rendered":"https:\/\/www.arisglobal.com\/?p=48955"},"modified":"2023-05-15T06:30:31","modified_gmt":"2023-05-15T06:30:31","slug":"biopharma-modernizes-pharmacovigilance-operations","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/","title":{"rendered":"How Leading South Korean Biopharma LSK is Modernizing Pharmacovigilance Operations with ArisGlobal"},"content":{"rendered":"<p>South Korean Contract Research Organization, LSK, spoke in a webinar with ArisGlobal to address the pressures of <a href=\"https:\/\/www.arisglobal.com\/blogs\/select-automated-drug-safety-platform\/\">modernizing pharmacovigilance operations<\/a> in the current landscape, including how South Korean biopharma firms are navigating evolving regulatory requirements, and how they are seizing the opportunity provided by advancements in end-to-end safety automation.<\/p>\n<h2><\/h2>\n<h2>Challenges for many South Korean CROs<\/h2>\n<p>Traditional safety workflows are inefficient, labor-intensive, and contain multiple manual, time-consuming steps. They are also cost-effective to scale, which makes it difficult to stay cost-competitive and efficiently deliver the level of service that clients expect (or demand). To grow a serviceable market, CROs and service providers need to meet increasingly complex global regulations, but manually ensuring compliance across global clients increases costs and complexities are challenging.<\/p>\n<p>Legacy workflows impair the ability to process higher case volumes and add new services. This makes it harder to scale post-market operations and be a one-stop-shop vendor.<\/p>\n<h2><\/h2>\n<h2>The State of Pharmacovigilance Regulation Updates in South Korea<\/h2>\n<p>Globally, pharmacovigilance regulations are constantly changing in terms of analyzing safety information worldwide. Increasing demand and industry competition, partnered with complex regulations and global operations makes for a complex landscape to navigate.<br \/>\nSince South Korea became a member of the <a href=\"https:\/\/www.ich.org\/\">International Council for Harmonisation<\/a> (ICH) in 2016, there have been many changes in regulatory requirements that CROs, like LSK, have had to navigate:<\/p>\n<ul>\n<li>Recently <a href=\"https:\/\/ich.org\/page\/e2br3-individual-case-safety-report-icsr-specification-and-related-files\">REICH E2B (R3)<\/a> type database was introduced in South Korea\u2019s Ministry of Food and Drug Safety (MFDS) as a reporting form of pharmaceutical safety information. Safety data was also reported in WHO-ART as the MedDRA dictionary was introduced<\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-0.pdf\">Periodic benefit-risk evaluation report (PBRER)<\/a> was introduced as a risk management plans (RMP) implementation result report, and development update safety report (DSUR) will be introduced in stages from June 2023<\/li>\n<li>Improvements to the RMP system and renewal of product approval is also part of the changing regulations and as a result, scientists need to analyze the risks and benefits of the drug to adhere to these changes<\/li>\n<li>As the database of the MDFS collected data in the form of E2B (R3), large-volume reports of adverse events reported during post-marketing drugs in Excel form now must be reported in XML form of E2B (R3)<\/li>\n<\/ul>\n<h2><\/h2>\n<h2>CROs and Service Providers are at a Crossroads<\/h2>\n<p>Today we are finding that globally, CROs and service providers are at a breaking point. According to industry biopharma trend reports, big pharma companies are <a href=\"https:\/\/www.biopharmatrend.com\/post\/146-the-evolving-pharma-rd-outsourcing-industry-a-birds-eye-view\/\">currently outsourcing 40-45% of their activities<\/a>, which is projected to grow to 60% and the outsourcing market is set to grow to $91.4B by 2028 to meet rising demands. In turn, many CROs, and many service providers are struggling to compete amid shifting demands.<\/p>\n<p>What are key safety priorities for CRO\u2019s and service providers?<\/p>\n<ol>\n<li>Flexibility \u2013 adapt to client requirements with flexible configuration of workflows and reports<\/li>\n<li>Scalability \u2013 Strengthening full-service model with seamlessly scalable post-market safety operations<\/li>\n<li>Efficiency \u2013 Deliver scalable compliance with the same resources with end-to-end production-ready automation<\/li>\n<li>Always Up-to-Date Global Compliance \u2013 Expand the serviceable market with support for major and regional regulations using a secure cloud-based architecture with open infrastructure<\/li>\n<li>Speed \u2013 Increase the speed of specialized treatments to market effectively<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>ArisGlobal offers a <a href=\"https:\/\/lifesphere.arisglobal.com\/platform\/safety\/multivigilance-system\/\">fully automated, end-to-end solution<\/a> that is tackling these key safety priorities head on. To further accelerate the early-and late-stage development of services for our CRO customers, we have invested in new products, solutions, and services that match this ever-evolving industry.<\/p>\n<p>To learn more about how ArisGlobal is helping to evolve South Korean regulatory requirements, <a href=\"https:\/\/event.on24.com\/wcc\/r\/4102230\/18F4E27E3189CD120200CBB1575C0877\">access the on-demand webinar<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>South Korean Contract Research Organization, LSK, spoke in a webinar [&hellip;]<\/p>\n","protected":false},"author":27,"featured_media":48956,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[32,93,99,157,164,165,166],"class_list":["post-48955","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs","tag-webinar","tag-pharmacovigilance","tag-lifesphere-safety","tag-safety","tag-biopharma","tag-cro","tag-south-korea"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.4 (Yoast SEO v23.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How Biopharma LSK Modernized Pharmacovigilance Operations<\/title>\n<meta name=\"description\" content=\"Discover how LSK modernized their pharmacovigilance operations and embraced and end-to-end safety solution with LifeSphere.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How Leading South Korean Biopharma LSK is Modernizing Pharmacovigilance Operations with ArisGlobal\" \/>\n<meta property=\"og:description\" content=\"Discover how LSK modernized their pharmacovigilance operations and embraced and end-to-end safety solution with LifeSphere.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/\" \/>\n<meta property=\"og:site_name\" content=\"ArisGlobal\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/LifeSphereAG\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-05-15T06:30:31+00:00\" \/>\n<meta name=\"author\" content=\"Mladen Prenc\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mladen Prenc\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/\"},\"author\":{\"name\":\"Mladen Prenc\",\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974\"},\"headline\":\"How Leading South Korean Biopharma LSK is Modernizing Pharmacovigilance Operations with ArisGlobal\",\"datePublished\":\"2023-05-15T06:30:31+00:00\",\"dateModified\":\"2023-05-15T06:30:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/\"},\"wordCount\":591,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.arisglobal.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage\"},\"thumbnailUrl\":\"\",\"keywords\":[\"Webinar\",\"Pharmacovigilance\",\"LifeSphere Safety\",\"safety\",\"biopharma\",\"CRO\",\"south korea\"],\"articleSection\":[\"Blog\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/\",\"url\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/\",\"name\":\"How Biopharma LSK Modernized Pharmacovigilance Operations\",\"isPartOf\":{\"@id\":\"https:\/\/www.arisglobal.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage\"},\"thumbnailUrl\":\"\",\"datePublished\":\"2023-05-15T06:30:31+00:00\",\"dateModified\":\"2023-05-15T06:30:31+00:00\",\"description\":\"Discover how LSK modernized their pharmacovigilance operations and embraced and end-to-end safety solution with LifeSphere.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage\",\"url\":\"\",\"contentUrl\":\"\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.arisglobal.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"How Leading South Korean Biopharma LSK is Modernizing Pharmacovigilance Operations with ArisGlobal\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.arisglobal.com\/#website\",\"url\":\"https:\/\/www.arisglobal.com\/\",\"name\":\"ArisGlobal\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/www.arisglobal.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.arisglobal.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.arisglobal.com\/#organization\",\"name\":\"LifeSphere\",\"url\":\"https:\/\/www.arisglobal.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"LifeSphere\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/LifeSphereAG\/\",\"https:\/\/www.linkedin.com\/products\/aris-global-lifesphere\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974\",\"name\":\"Mladen Prenc\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How Biopharma LSK Modernized Pharmacovigilance Operations","description":"Discover how LSK modernized their pharmacovigilance operations and embraced and end-to-end safety solution with LifeSphere.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/","og_locale":"en_US","og_type":"article","og_title":"How Leading South Korean Biopharma LSK is Modernizing Pharmacovigilance Operations with ArisGlobal","og_description":"Discover how LSK modernized their pharmacovigilance operations and embraced and end-to-end safety solution with LifeSphere.","og_url":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/","og_site_name":"ArisGlobal","article_publisher":"https:\/\/www.facebook.com\/LifeSphereAG\/","article_published_time":"2023-05-15T06:30:31+00:00","author":"Mladen Prenc","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Mladen Prenc","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#article","isPartOf":{"@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/"},"author":{"name":"Mladen Prenc","@id":"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974"},"headline":"How Leading South Korean Biopharma LSK is Modernizing Pharmacovigilance Operations with ArisGlobal","datePublished":"2023-05-15T06:30:31+00:00","dateModified":"2023-05-15T06:30:31+00:00","mainEntityOfPage":{"@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/"},"wordCount":591,"commentCount":0,"publisher":{"@id":"https:\/\/www.arisglobal.com\/#organization"},"image":{"@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage"},"thumbnailUrl":"","keywords":["Webinar","Pharmacovigilance","LifeSphere Safety","safety","biopharma","CRO","south korea"],"articleSection":["Blog"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/","url":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/","name":"How Biopharma LSK Modernized Pharmacovigilance Operations","isPartOf":{"@id":"https:\/\/www.arisglobal.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage"},"image":{"@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage"},"thumbnailUrl":"","datePublished":"2023-05-15T06:30:31+00:00","dateModified":"2023-05-15T06:30:31+00:00","description":"Discover how LSK modernized their pharmacovigilance operations and embraced and end-to-end safety solution with LifeSphere.","breadcrumb":{"@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#primaryimage","url":"","contentUrl":""},{"@type":"BreadcrumbList","@id":"https:\/\/www.arisglobal.com\/blogs\/biopharma-modernizes-pharmacovigilance-operations\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.arisglobal.com\/"},{"@type":"ListItem","position":2,"name":"How Leading South Korean Biopharma LSK is Modernizing Pharmacovigilance Operations with ArisGlobal"}]},{"@type":"WebSite","@id":"https:\/\/www.arisglobal.com\/#website","url":"https:\/\/www.arisglobal.com\/","name":"ArisGlobal","description":"","publisher":{"@id":"https:\/\/www.arisglobal.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.arisglobal.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.arisglobal.com\/#organization","name":"LifeSphere","url":"https:\/\/www.arisglobal.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"LifeSphere"},"image":{"@id":"https:\/\/www.arisglobal.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/LifeSphereAG\/","https:\/\/www.linkedin.com\/products\/aris-global-lifesphere\/"]},{"@type":"Person","@id":"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974","name":"Mladen Prenc"}]}},"_links":{"self":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/posts\/48955"}],"collection":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/users\/27"}],"replies":[{"embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/comments?post=48955"}],"version-history":[{"count":0,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/posts\/48955\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/media?parent=48955"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/categories?post=48955"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.arisglobal.com\/wp-json\/wp\/v2\/tags?post=48955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}