{"id":8354,"date":"2017-04-05T06:50:34","date_gmt":"2017-04-05T06:50:34","guid":{"rendered":"https:\/\/arisglobal.com\/bkp-site\/?p=8354"},"modified":"2017-04-05T06:50:34","modified_gmt":"2017-04-05T06:50:34","slug":"secret-weapon-act-idmp-assessment","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/secret-weapon-act-idmp-assessment\/","title":{"rendered":"A Secret Weapon to Act on Your IDMP Assessment"},"content":{"rendered":"<div style=\"padding-right: 10px;\">\n<\/div>\n<div>\n<p>If you\u2019re in Regulatory Affairs, you know the IDMP-compliance-truck is headed your way. Which questions though are plaguing your team?<\/p>\n<ul style=\"padding-left: 21em;\">\n<li>Wondering how to work on the recommendations from an initial IDMP Readiness Assessment?<\/li>\n<li>Still evaluating if an initial IDMP-readiness assessment will give you concrete visibility on how you will tackle the compliance challenge?<\/li>\n<li>Or completely weighed under by the \u2018Plan a lot; do nothing yet\u2019 worry?<\/li>\n<\/ul>\n<p>Now is the time to get into some concrete action. It\u2019s time to put the Identification of Medicinal Products (IDMP) assessment conclusions and recommendations in action using technology solutions that can help you validate the assessment, refine data collection process definitions and kickstart the data collection process. If you haven\u2019t embarked on the assessment journey yet, it\u2019s high time to understand how technology innovation in regulatory compliance space can launch and support your assessment phase.<\/p>\n<\/div>\n<h2 style=\"clear: both;\"><strong>What Does It Mean to Use Technology Solutions to Solve Your Assessment?<\/strong><\/h2>\n<p>To be clear, we aren\u2019t talking about the \u201cbig bang,\u201d long-term approach. We are talking about an immediate, get your organization some fast answers based on what you know \u2013 to inform a longer-term, more involved strategy. It\u2019s an approach not often considered, which is why organizations get stuck in \u201canalysis paralysis.\u201d We like to think of it as your secret-weapon.<\/p>\n<p>And the timing can\u2019t be more immediate. EMA is going live with referentials and organizations part of IDMP this year. That has immediate impact on you for continuity on xEVMPD compliance. Delay in IDMP deadlines doubles up the challenge. How do you ensure you continue to submit xEVMPD data in compliance with EMA\u2019s new systems &#8211; RMS and OMS, while also leveraging that investment to collect data in an&nbsp;IDMP-compliant fashion in readiness for the changeover and not having to implement changed processes and systems multiple times?<\/p>\n<p>To address this challenge, you need to leverage a solution that enables you to:<\/p>\n<ul>\n<li><strong>Boost productivity<\/strong> of your regulatory data team by using automation to quickly convert your existing xEVMPD compliant data into a central data hub that is xEVMPD + IDMP compliant<\/li>\n<li><strong>Ensure compliance<\/strong> by leveraging integration with EMA\u2019s RMS and OMS systems in a system that then help you align and re-code your product information to latest controlled vocabulary and organization information from EMA<\/li>\n<li><strong>Improve data quality<\/strong> by validating your central product data dictionary against relevant current xEVMPD business rules to ensure all required data is in place<\/li>\n<li><strong>Create a sustainable maintenance process<\/strong> by making electronic gateway-based submissions to the xEVMPD database in readiness for IDMP where web application-based method is no longer recommended due to sheer volumes and maintenance overhead<\/li>\n<li><strong>Benefit from reduced rework by re-using <\/strong>the central product dictionary for implementing the IDMP assessment recommendations on an IDMP Pilot with showcase products \u2013 old historically approved ones, those with multiple-language labeling, combination kit products, approved using varied group procedures in EU<\/li>\n<li><strong>Kickstart IDMP data collection with <\/strong>coverage against either iteration 1 or the full IDMP scope by testing central product dictionary against IDMP business rules from ISO and eventually from EMA, FDA, HealthCanada and other agencies<\/li>\n<li><strong>Use quantitative metrics to benchmark <\/strong>current data quality and identify effort required to augment data to be fully IDMP compliant in order to plan for the resources and process optimization budget for upcoming years<\/li>\n<\/ul>\n<p>Invest in a technology solution that enables you to clearly visualize the end state as recommended by your&nbsp;assessments, or enables you to effective conduct a pilot to actually assess and benchmark your current data quality and effort to reach To-be state.<\/p>\n<p>Talk to <a class=\"pressRelLink\" href=\"https:\/\/www.arisglobal.com\/contact-us\/\">ArisGlobal experts<\/a> to understand more about this \u2018<em>Transformation Enablement via Technology Innovation<\/em>\u2019 approach and get a demonstration of ArisGlobal\u2019s Global Data Standards Compliance Solution <a class=\"pressRelLink\" href=\"https:\/\/arisglobal.com\/products\/lifesphere-idmp-agidmp\/\">LifeSphere IDMP<\/a> that is available on its new ifeSphere<sup style=\"font-size:12px;\">\u00ae<\/sup> cloud-based technology platform.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>If you\u2019re in Regulatory Affairs, you know the IDMP-compliance-truck is [&hellip;]<\/p>\n","protected":false},"author":27,"featured_media":8363,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[83,91],"class_list":["post-8354","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs","tag-arisglobal-blogs","tag-idmp"],"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>A Secret Weapon to Act on your IDMP Assessment | ArisGlobal<\/title>\n<meta name=\"description\" content=\"What does It mean to use technology solutions to solve your IDMP assessment? Read this ArisGlobal blog to learn how to leverage this \u201csecret weapon.\u201d\" \/>\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\/secret-weapon-act-idmp-assessment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A Secret Weapon to Act on Your IDMP Assessment\" \/>\n<meta property=\"og:description\" content=\"What does It mean to use technology solutions to solve your IDMP assessment? 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