EU M1 Changes Require Action from Publishing Vendors

Europe recently made some fairly significant changes to eCTD Module 1 Guidance. You can see and download the specification, release notes, examples, and overall package at: http://esubmission.emea.europa.eu/eumodule1/. Look for an update from your publishing vendor as DTD and publishing tool changes are needed to support the new spec – and remember that EMEA has said that they require compliance by the end of 2008, so plan now...

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