Category Archives: Conference

Conference related posts

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 Delays New eCTD Module 1

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At last week’s DIA Annual Meeting in Boston the FDA announced that the long awaited new eCTD Module 1 would be delayed until June 2014. In addition, the FDA is changing the DTD. So, if you have been waiting for the FDA to start accepting the new M1 so you could add your documents into those 4 new sections at the end of M1, you’re going to have to wait about another year longer.

DIA EDM/eSubs only 2.5 weeks away

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The DIA EDM/eSubs conference, or as the DIA calls it, “EDM and ERS/eCTD 2012” , being held at the Baltimore Hilton Hotel from October 9-11, 2012 (Tutorials: October 8), is only 2 weeks away. Find out more at http://www.diahome.org/en/Flagship-Meetings/12003-EDM.aspx . And while you’re there, stop by the Sage Submissions booth (#301) and find out how Sage Templates can make the preparation of your Regulatory documents easier and more accurate and the new features of v2.