Continuous publishing replaces serial publishing with a parallel process where regulatory teams identify issues in real time rather than waiting until the end. This allows regulatory teams to resolve validation errors faster and eliminate cumbersome manual handoffs to significantly reduce time from planning to submission.
The realm of regulatory affairs is in constant flux with new standards, best practices, and processes emerging every day. With each interaction with each product that’s filed, and with each product that’s approved, the regulatory experience is broadened.
Demetra Macheras serves as director, regulatory policy and intelligence, in regulatory affairs for AbbVie, Inc. At the DIA 2018 Global Annual Meeting Demetra served as a panelist to provide the industry perspective in the session titled “Navigating the Regulatory Landscape of Drug-Device Combination Products” and was interviewed after this session for this podcast.