{"id":13040,"date":"2018-01-09T05:30:28","date_gmt":"2018-01-09T05:30:28","guid":{"rendered":"https:\/\/arisglobal.com\/bkp-site\/?p=13040"},"modified":"2018-01-09T05:30:28","modified_gmt":"2018-01-09T05:30:28","slug":"regulatory-affairs-automation-greatest-regulatory-challenges","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/regulatory-affairs-automation-greatest-regulatory-challenges\/","title":{"rendered":"Is Regulatory Affairs Ready for Automation? Part 1: What Is Your Greatest Regulatory Challenge?"},"content":{"rendered":"

On December 6th, 2017, ArisGlobal held a webcast in partnership with DIA titled <\/em>\u201cIs Regulatory Affairs Ready for Automation?\u201d In this webinar, our presenter, <\/em>David Scanlon<\/em><\/a>, Senior Director of Regulatory Strategy, posed three related polling questions to the audience, and their responses to each came up with some interesting information. This is the first in a three-part blog series that analyzes these responses, and shares our thinking about what they mean to our clients in the Regulatory space. <\/em><\/p>\n

Automation technologies are having a major impact on performance and productivity across industries. In regulatory, these technologies also have the potential to reshape many activities across regulatory, leading to significant productivity gains. While there\u2019s a lot of talk about how automation technologies will create new roles with exciting opportunities, the most powerful impact will be on the data quality and the efficiency with which manual tasks will be accomplished.<\/p>\n

Interesting findings were revealed from the three polling questions conducted with the 81 webcast participants, which included 8 of the top 10 pharmaceutical companies, 4 of the top 5 pharma consultancy firms, as well as CROs, CMOs, medical device companies and veterinary services from 10 countries (Canada, Denmark, Germany, India, Ireland, Japan, Netherlands, Sweden, UK, USA)<\/strong>.<\/p>\n

The broad spread of participants shows the increasing challenges hitting regulatory organizations coming from new device legislation, serialization within supply chain and data exchange (SPOR) \u2013 all of which are hitting pharma and veterinary organizations. The struggles are clear within regulatory, with many already starting a journey to correct legacy pain points.<\/p>\n

With five possible responses to choose from, our first polling question asked webinar attendees to identify their greatest regulatory challenge:<\/p>\n