Top Recommendation from the Regulatory Track at Veeva’s 2016 R&D Summit

There was one piece of advice repeated by virtually every company speaking in the regulatory track, and that was to manage all submissions, even the little ones, with a system-driven workflow. The speakers provided a few different reasons for employing workflows consistently across submissions. Frank Bosley from The Medicines Company spoke of the value of having an authoritative source and complete historic record of what was submitted. Kelly Gage-Michaels from Regeneron described how workflows within Veeva Vault RIM do not have to be one‑size‑fits‑all for your submission documents. Flexible workflows can be built to facilitate the way you work. This can be a welcomed departure from systems that can’t bend and flex the way you need them to. By running submission documents through workflows, metrics can then be analyzed to make more informed business decisions. Craig Gassman from Karyopharm Therapeutics described how workflow data helped them automate tracking activities, and using workflows for every submission plays a role in eliminating tracking spreadsheets.

It was interesting to see three different perspectives and rationales, each reinforcing the same point: once you’ve established workflows for assembling and processing submissions, it’s important to adhere to your regimen. The business benefits are clear: a reliable historic record, useful business insights, and greater operating efficiency.

For additional observations on how regulatory teams are able to generate and leverage new business insights, read The Expanding Role of Regulatory Operations, a recent article in RAPS Regulatory Focus.