{"id":8350,"date":"2017-04-10T04:50:57","date_gmt":"2017-04-10T04:50:57","guid":{"rendered":"https:\/\/arisglobal.com\/bkp-site\/?p=8350"},"modified":"2017-04-10T04:50:57","modified_gmt":"2017-04-10T04:50:57","slug":"think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/","title":{"rendered":"Think Big: Regulatory Affairs Must Prepare to Respond to Strategic Business Drivers"},"content":{"rendered":"<p>Regulatory affairs departments are accustomed \u2013 and even open &#8212; to change and adapting their technology and processes in response to compliance and business pressures. Typically, regulatory affairs leaders respond to such drivers as \u201chow do we improve efficiency?,\u201d \u201chow do we speed the process to improve time to market?,\u201d and \u201cwhat do we need to do to get the right information from affiliates on time?\u201d<\/p>\n<p>&nbsp;<\/p>\n<p>But in an age of heightened collaboration combined with a push for greater harmonization around the way products are developed, manufactured, delivered, marketed, and reimbursed, regulatory affairs is having to consider wider business drivers.<\/p>\n<p>&nbsp;<\/p>\n<p>That\u2019s not to say that efficiency, time to approval, and affiliate management aren\u2019t important, but rather that these are operational issues, whereas business drivers extend far beyond into strategic business matters.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Regulatory Affairs: Prepare for Disruption<\/strong><\/h3>\n<p>&nbsp;<\/p>\n<p style=\"text-align: left;\">It\u2019s clear now that for the regulatory affairs industry to transform and respond to disruptive innovation, it must move away from point solutions and start to respond \u2013 from a process and technology point of view \u2013 to the larger drivers the entire company is facing. Those drivers have potentially huge ramifications for industry, including pricing pressures, audit expectations, managing the supply chain, and the transfer of documentation across the enterprise and beyond.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: left;\">Equally, those drivers extend into new ways of doing business and interacting: the Internet of Things, social media, artificial intelligence, and blockchain technologies.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: left;\">While regulatory affairs may well question how many of these issues affect them, the reality is in today\u2019s more connected environment they soon will, and progressive organizations should prepare now by building the 2020 regulatory information management (RIM) technology landscape to successfully manage the transformation. Quite simply, regulatory \u2013 and indeed any department \u2013 can\u2019t go it alone, they need to work collaboratively to tackle the disruption that can potentially advance innovation.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: left;\">Over the next few weeks\u00a0we&#8217;ll explore the themes of cross-functional business drivers and next-generation digital trends, how these are impacting regulatory affairs, and technology responses affecting the regulatory compliance management system that are needed to achieve future success.<\/p>\n<p>&nbsp;<\/p>\n<p><em><strong>Join Pratyusha Pallavi, Product Manager &#8211; Regulatory,\u00a0at the eRegulatory Summit, April 25-27 in Madrid, where she\u2019ll be presenting on the topic of Regulatory 2020: Technology-Fueled Business Transformation, and where <a class=\"pressRelLink\" href=\"https:\/\/www.arisglobal.com\/regulatory-affairs\">ArisGlobal<\/a> will be also exhibiting<\/strong>.<\/em><\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulatory affairs departments are accustomed \u2013 and even open &#8212; [&hellip;]<\/p>\n","protected":false},"author":27,"featured_media":8352,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[83,90],"class_list":["post-8350","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs","tag-arisglobal-blogs","tag-regulatory-information-management"],"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>Regulatory Affairs Should Respond to Strategic Business Drivers | ArisGlobal<\/title>\n<meta name=\"description\" content=\"ArisGlobal expert shares how life science organizations should prepare for 2020 regulatory affairs RIMS technology landscape. Read the Blog\" \/>\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\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Think Big: Regulatory Affairs Must Prepare to Respond to Strategic Business Drivers\" \/>\n<meta property=\"og:description\" content=\"ArisGlobal expert shares how life science organizations should prepare for 2020 regulatory affairs RIMS technology landscape. Read the Blog\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/\" \/>\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=\"2017-04-10T04:50:57+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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/\"},\"author\":{\"name\":\"Mladen Prenc\",\"@id\":\"https:\/\/www.arisglobal.com\/#\/schema\/person\/bb2c7aafe44a090bcd667448651eb974\"},\"headline\":\"Think Big: Regulatory Affairs Must Prepare to Respond to Strategic Business Drivers\",\"datePublished\":\"2017-04-10T04:50:57+00:00\",\"dateModified\":\"2017-04-10T04:50:57+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/\"},\"wordCount\":399,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.arisglobal.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/#primaryimage\"},\"thumbnailUrl\":\"\",\"keywords\":[\"ArisGlobal Blogs\",\"regulatory information management\"],\"articleSection\":[\"Blog\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/\",\"url\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/\",\"name\":\"Regulatory Affairs Should Respond to Strategic Business Drivers | ArisGlobal\",\"isPartOf\":{\"@id\":\"https:\/\/www.arisglobal.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.arisglobal.com\/blogs\/think-big-regulatory-affairs-must-prepare-respond-strategic-business-drivers\/#primaryimage\"},\"thumbnailUrl\":\"\",\"datePublished\":\"2017-04-10T04:50:57+00:00\",\"dateModified\":\"2017-04-10T04:50:57+00:00\",\"description\":\"ArisGlobal expert shares how life science organizations should prepare for 2020 regulatory affairs RIMS technology landscape. 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