Notes from RAPS Advanced eCTD Workshop

This week’s blog posting is from Rahul Mistry, CEO of GlobalSubmit, who recently was a featured speaker at the RAPS workshop entitled “Advance eCTD Submissions”.  Rahul’s presentation focused on eCTD quality, a topic that obviously interested the audience based on the significant number of questions that he received. Two weeks ago I had the pleasure at presenting at an Advanced eCTD Workshop hosted by RAPS in...

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Specifications for Organizing Study Datasets

A few months ago, FDA issued version 1.5.1 of Study Data Specifications. Although the changes in the new version were not great, they were significant for eCTD as a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered and has no effect on the Table of Contents that is visible to a reviewer (created from the eCTD XML backbone)....

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Pharma Industry Survey Addresses Document Management Systems, eCTD Adoption

Recently, I caught up with my old friend Steve Gens (of Gens and Associates Inc.) to talk with him about a very interesting global survey he just completed on “Benchmarks of Emerging Technologies and Approaches for Collaboration and Document Management” in the Pharma industry. The 2009 survey was completed in partnership with Steve Scribner of International Life Sciences Solutions, as a follow-up to their well-received 2007 survey....

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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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Updates on eCTD Specification in Europe, Japan

EMEA and PMDA provided an update on eCTD status at the traditional “Update on Regulatory Authority Experience” session. Tim Buxton was the speaker from EMEA. He provided the following statistics on eCTDs received between July and December 2007: Centralised Procedure: 14 new applications, 80 variations National Procedures (as reported by national compentent authorities): 659 new applications, 611 variations Mr. Buxton also...

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