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On December 6th, 2017, ArisGlobal held a webcast in partnership with DIA titled “Is Regulatory Affairs Ready for Automation?” In this webinar, our presenter, David Scanlon, 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.

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’s 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.

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).

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) – 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.

With five possible responses to choose from, our first polling question asked webinar attendees to identify their greatest regulatory challenge:

  • Sixty nine percent (69%) of our webinar attendees cite data quality and lack of system integration as a major pain-points
  • Sixteen percent (16%) of our webinar attendees fully recognize the issues and have corrective measures in place (2020-25 strategies)

For us, the biggest surprise in this question’s results was that the inappropriate use of Microsoft Excel outside Regulatory platforms, for managing locally compliance related data, is not a big an issue.  All of the evidence our regulatory experts have collected from numerous industry discussions and experience gained from other business areas indicates that there are networks of local data management that are using Excel and SharePoint lists to overcome data quality and integration issues. Maybe it is time to re-think this hypothesis?

Automation promises to be a game-changer for regulatory affairs, decreasing the cost of data management and improving data quality to allow regulatory experts to focus on where they truly add value, finding innovative ways to get treatments faster to patients and ensuring no harm is done to patients with faster implementation of required changes to labels.

Repetitive and routine manual tasks in regulatory processes can be automated and tackled in a very sophisticated and seamless way. Automation can play a key role in decreasing the manual effort in document management, data collection, data management, data quality improvements and in preparation for data exchange with agencies (SPOR in EU and SPL in US).

We encourage you to view the on-demand webcast for more comparisons and insights into how automation is coming to life in Regulatory today. Our second blog in this 3-part series will be published shortly, and will share the results and feedback from our two other webcast polling questions.

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