Integrating Document Management and eCTD Publishing Systems
Apr26

Integrating Document Management and eCTD Publishing Systems

Most Tier I and Tier II sponsors maintain their submission documents in an electronic document management system (EDMS). It’s obvious that software that creates electronic (or paper) submissions must work with the documents managed in the EDMS. But what is not so obvious is the optimal integration between an EDMS and a publishing tool.

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EMEA Update on eCTD Implementation

Attending the DIA EU EDM Conference in December gave me a great opportunity to catch up on eCTD-related status and activities at various European agencies. We heard from a number of presenters representing EMEA (now just European Medicines Agency), the MEB, Swissmedic, and AGES PharmMed. Since the updates are fairly lengthy, today I’ll cover EMEA, and will address the other agencies in a future posting. Tim Buxton gave the update from...

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