Newsletter | March 19, 2020

03.19.20 -- How Continuous Publishing Speeds Regulatory Submissions

How Continuous Publishing Speeds Regulatory Submissions

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.

Regulatory Science 2019: Leading Or Holding Back Innovation?

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.

Regulatory Landscape Of Drug-Device Combination Products

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.

Featured DIA Event

Regulatory Track At the DIA 2020 Global Annual Meeting

June 14-18, 2020 | Washington, DC

The track is composed of sessions addressing global laws, regulations, guidelines, and guidances that govern prescription biopharmaceutical and device product development, approval, and maintenance.