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July 10, 2018
DIA 2018 meeting connects life sciences policy discussions to real-world knowledge
By: Sandy Krogulski

Recently I attended the DIA 2018 Global Annual Meeting, which was held in Boston from June 24-28. With more than 250 sessions across 12 tracks, it’s an event that helps to drive insights into action by connecting key policy discussions to real-world knowledge in life sciences and healthcare.

I was honored to be selected to speak this year as part of a session on understanding Electronic Submissions. My talk focused on how to manage lifecycle maintenance submissions with the Electronic Common Technical Document (eCTD). It was a lively discussion, hosted by Tessa Brown of the FDA, and I was joined by Julian Chun and Jonathan Resnick, also of the FDA.

When it comes to regulatory submissions, the eCTD offers a number of benefits, including enabling organizations to improve their ability to:

  • Review content,
  • Track information,
  • Reuse documents,
  • Manage global submissions, and
  • Reduce use of paper.

While the eCTD will go a long way toward helping companies manage the chaos of submissions, companies should also take the following steps to stay up to date with changes to the document and to regulations:

  • Evaluate and understand. It’s important to understand what stage the document is at, to know how far along your company is in terms of adopting the eCTD and how your team is structured, with internal talent and external vendors. I suggest developing a plan or team to manage periodic evaluations, so that your company can be proactive rather than reactive to changes and updates.
  • Define the process. This includes defining roles, developing standards, including a style guide, and developing a workflow that can be followed for each submission.
  • Collect metrics. Track issues, identify training needs and dedicate time to create real and lasting change, and realize the full benefits.
  • Update procedures. As guidance changes, consider how procedures can be modified to improve adherence.
  • Make use of technology and intelligence. Software, including RIM Technology, Submission Tracker and Submission Publisher, can help companies manage the submission process.
  • Keep an eye on what’s coming. You’ll want to stay abreast of updates in your geographic region as well as track industry trends.

It was interesting to note the common desire to increase harmonization of pharmaceutical standards across the globe. Sponsors and company representatives frequently discussed the challenges of meeting changing regulatory requirements, and preparing for updates that are coming but not yet officially endorsed.

I was impressed with the FDA’s openness in discussing changing specifications and coming updates to the electronic gateway and submissions. It’s not every day we get to hear the logic behind decisions for standardizing and automating processes, and so this was welcome information for many attendees.

Industry meetings like the DIA offer a great opportunity to spend time with leaders in this industry and learn about best practices and innovative new approaches. I look forward to attending and speaking at future events, to continue to share insights to advance discoveries in life sciences.

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