{"id":16509,"date":"2022-01-14T03:56:54","date_gmt":"2022-01-14T08:56:54","guid":{"rendered":"https:\/\/en.ennov.com\/?p=16509"},"modified":"2022-05-23T02:36:28","modified_gmt":"2022-05-23T07:36:28","slug":"2-1-ema-idmp-implementation-guide","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/blog\/regulatory-blog\/2-1-ema-idmp-implementation-guide\/","title":{"rendered":"Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide"},"content":{"rendered":"\n<p>With the ever-changing landscape of RIM system compliance, it\u2019s crucial to remain up to speed with the latest guidelines. In this article, discover the changes from Version 2.1 of the EMA IDMP Implementation Guide (IG) that was published June 30th, 2021.<\/p>\n\n\n\n<p>For an in-depth examination of this update, be sure to download our <strong><a href=\"https:\/\/en.ennov.com\/insider\/regulatory\/idmp-compliance-version-9-2\/\">free Industry Brief<\/a><\/strong> that not only outlines these changes, but also provides analysis and solutions that can help pave the path to compliance.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Additions and Modifications of Data Elements<\/h2>\n\n\n\n<p>Although a minor IG update was expected, the latest revision to the IDMP data chapter proved rather extensive with the introduction of new data elements as well as changes to existing data elements. Additionally, comprehensive process details were provided. The main takeaways from the Chapter 2 revisions are:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The addition of the Genetically Modified Organisms (GMO) field<\/li><li>General, editorial, and technical clean-up of the guidance document<\/li><li>The Provenance, or reason for sending the IDMP message, was clarified<\/li><li>MedDRA and ATC codes can now be used directly without the need for an RMS mapped term<\/li><\/ul>\n\n\n\n<p>Looking for an analysis of these changes? Get free access to the industry brief: <strong><a href=\"https:\/\/en.ennov.com\/insider\/regulatory\/idmp-compliance-version-9-2\/\">Maintaining Compliance: Adapting to Changing Requirements<\/a><\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">A Solution That Ensures Compliance<\/h2>\n\n\n\n<p>The Digital Application Dataset Integration (DADI) is increasingly interconnected with the IDMP (Identification of Medicinal Product). Evidently, these projects are aligning since DADI manages the data related to the procedure, and IDMP manages the data related to the product.<\/p>\n\n\n\n<p>While the details for the next update remains unknown, Ennov RIM\/IDMP has consistently responded quickly to new guidance updates. Ennov RIM\/IDMP is a scalable, flexible and open platform, meaning it easily adapts to the changing regulatory requirements. For example, since the last two versions of the IDMP IG 2.0 and 2.1, Ennov RIM\/IDMP was able to implement these regulatory updates in under 2 months.<\/p>\n\n\n\n<p>While the Ennov platform will continue to incorporate new innovations, Ennov\u2019s current track record should establish confidence that clients\u2019 needs and timelines are met even when unexpected regulatory updates occur.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>With the ever-changing landscape of RIM system compliance, it\u2019s crucial to remain up to speed with the latest guidelines. In this article, discover the changes from Version 2.1 of the EMA IDMP Implementation Guide (IG) that was published June 30th, 2021. For an in-depth examination of this update, be sure to download our free Industry [&hellip;]<\/p>\n","protected":false},"author":232,"featured_media":16895,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[177,147],"tags":[133,127],"type_content":[],"job":[],"employees_type":[],"class_list":["post-16509","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-regulatory-blog","tag-idmp","tag-rim","entry","has-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.2.1 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide<\/title>\n<meta name=\"description\" content=\"Keep up with the ever-changing landscape of RIM system compliance and remain up to speed with the latest guidelines. (EMA IDMP IG)\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide\" \/>\n<meta property=\"og:description\" content=\"Keep up with the ever-changing landscape of RIM system compliance and remain up to speed with the latest guidelines. (EMA IDMP IG)\" \/>\n<meta property=\"og:url\" content=\"https:\/\/dqdev.co\/ennov\/blog\/regulatory-blog\/2-1-ema-idmp-implementation-guide\/\" \/>\n<meta property=\"og:site_name\" content=\"Ennov Software for Life\" \/>\n<meta property=\"article:published_time\" content=\"2022-01-14T08:56:54+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-05-23T07:36:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/dqdev.co\/ennov\/wp-content\/uploads\/2022\/01\/Version-2-1-IG-IDMP.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"627\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Alex Chappell\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/dqdev.co\/ennov\/wp-content\/uploads\/2022\/01\/Version-2-1-IG-IDMP.png\" \/>\n<meta name=\"twitter:creator\" content=\"@EnnovGroup\" \/>\n<meta name=\"twitter:site\" content=\"@EnnovGroup\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Alex Chappell\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/\"},\"author\":{\"name\":\"Alex Chappell\",\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/#\\\/schema\\\/person\\\/ebc4deb7c360f7a979b3af96c6150941\"},\"headline\":\"Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide\",\"datePublished\":\"2022-01-14T08:56:54+00:00\",\"dateModified\":\"2022-05-23T07:36:28+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/\"},\"wordCount\":343,\"publisher\":{\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/wp-content\\\/uploads\\\/2022\\\/01\\\/EMA.jpg\",\"keywords\":[\"IDMP\",\"RIM\"],\"articleSection\":[\"Blog\",\"Regulatory - Blog\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/\",\"url\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/\",\"name\":\"Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/blog\\\/regulatory-blog\\\/2-1-ema-idmp-implementation-guide\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dqdev.co\\\/ennov\\\/wp-content\\\/uploads\\\/2022\\\/01\\\/EMA.jpg\",\"datePublished\":\"2022-01-14T08:56:54+00:00\",\"dateModified\":\"2022-05-23T07:36:28+00:00\",\"description\":\"Keep up with the ever-changing landscape of RIM system compliance and remain up to speed with the latest guidelines. 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