Category Archives: Software

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DIA “EDM and ERS/eCTD 2014” Conference September 22-24, 2014

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The DIA “EDM and ERS/eCTD 2014” conference is being held at the Omni Shoreham Hotel, 2500 Calvert Street NW, Washington, DC 20008, on September 22-24, 2014 (tutorials the day before). Click here for more information including the agenda and hotel information.

While you’re at the show let’s connect! Write me on the Contact Us form and click “Let’s Meet” and in the comments section let me know what’s a good time to meet and how we can help you. Or call us at 206-734-0500 (Seattle time!).

And while you’re there, stop by the booths of our Partners:

  • EXTEDO to review the new features of the latest release of eCTDmanager and learn of other eRegulatory Solutions.
  • RegDocs365 and find out more about hosted Regulatory solutions; plus I’m helping them out in the booth so stop by and say “hi”.

And be sure to mention that 515 Consulting sent you!

FDA releases new eCTD Module 1 documents

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As mentioned in my last post, at the DIA Annual Meeting in Boston at the end of June, the FDA announced that the implementation of the long awaited new eCTD Module 1 would be delayed until June 2014. The FDA has now released 4 guidance documents for vendors and industry to prepare for the new Module 1:

There are many advantages for migrating eCTDs to the new Module 1 format. 515 Consulting Group uses EXTEDO’s eCTDmanager to prepare and publish eCTD submissions to the FDA and other Authorities around the world and since we will want to migrate our client’s eCTDs when the time comes, we asked Karteek Sandadi, Professional Services Manager for EXTEDO in North America when eCTDmanager will support the new M1 functionality. We were pleased to learn that EXTEDO plans to support the new FDA M1 functionality in eCTDmanager in the Q1 2014 timeframe. We look forward to trying it out.

FDA Posts eCTD Validation Specifications v2.2

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Yes that’s right, 2.2! As you may know, FDA started using Validation Criteria 2.1 on 30 April. In the 2.1 spec all the new/changed items had an “Effective Date” of “Pending”. All 2.2 does is change all the “Pending” to “4/30/2013”. No items were added/deleted/changed. Click here to download the new 2.2 version specifications from the FDA website.

And don’t forget to validate your own eCTDs with v 2.1/2.2 specs now!