FDA’s New Module 1 is a Bridge to eCTD 4
Sep13

FDA’s New Module 1 is a Bridge to eCTD 4

The evolution of the Electronic Common Technical Document (eCTD) has been a progression. More features and functionality become available to users as new versions are introduced. User adoption of eCTD also increases year over year. FDA Module 1 v2.3 (DTD 3.3) is a bridge to eCTD 4. A number of functionality enhancements set for inclusion in eCTD v4 first appeared in the new FDA M1 but were not present in FDA eCTD M1 (DTD 2.01). The shared features, presently implemented in FDA M1 v2.3 (DTD 3.3) and included in eCTD 4, are coded metadata, in the form of Controlled Vocabularies, and Grouped Submissions.

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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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EDM Reference Model Metadata and eCTD Submissions

Many of you are no doubt familiar with the EDM Reference Model. This is a cross-SIAC initiative by the DRM (Document and Records Management (DRM) SIAC. [A SIAC is a Special Interest Area Community within DIA.] As a quick refresher, the goal of this group is to define a minimum set of metadata to enable the context of use of regulatory submission for CTD documents and supporting documents. In other words, what metadata should be used...

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Top 10 Validation Errors for Health Canada

  The AAPS Workshop on Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now! was held March 9-11, 2009. There were some great presentations, and best of all they are publically available. The agenda contains links to the presentations. All the presentations were good but some of the highlights for me appear below. There’s great information on Japan and Health Canada that has been rather...

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