Happy Holidays from eCTDBlog.com

Thanks for reading, have a happy holiday season and a prosperous New Year!

Turkish NeeS Standard

Crawling around LinkedIn, I found another interesting point -- the impacts of the standardized CTD structure are slowly being adopted even outside of the "official" ICH regions of the US, Europe, Japan (and Canada). We've seen this with recent Australian and Swiss guidance, but additional regions and regulators are accepting submission aligned with the CTD.

For example, Turkey appears to be accepting a NeeS-like format aligned with the CTD structure. In it, Turkish versions of the ICH folder structure used in the eCTD and NeeS are recommended, along with several PDF-based TOCs at the Module level.

Translation -- I had to jump through hoops to get this to work. Scroll down to the bottom, but formatting is lost and it is difficult to read. The original "Slide" has the original unstranslated Turkish document.
Original Guidance from Turkish Agency

Is anyone else familiar with other CTD-based standards in use outside of ICH regions?

Bulgaria Wants eCTD\NeeS in 2010

Fun with Google Translate:

Ръководство за електронно подаване на документи eCTD и Nees
(Guide for electronic submission of documents and eCTD Nees)

To celebrate, if you are in the New York city area, why not have an extra large Bulgarian beer or icy cold shot of Vodka at Mehanata, the Bulgarian Bar on the Lower East Side?

Liquent To Be Sold by Thomson Reuters?

It appears as though Liquent, a division of Thomson Reuters will be sold to Marlin Equity, a California-based private investment firm that holds and manages business in many different spaces.

It will be interested to see how, if at all, this impacts Liquent which manages several eCTD and related software packages.

Great Article on Early Adoption of EDMS and Impacts, including Publishing

http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=3933

Excerpt:

WHAT ARE THE MAJOR STUMBLING BLOCKS THAT CAUSE ELECTRONIC DOCUMENT MANAGEMENT PROJECTS TO BE UNSUCCESSFUL?
Gens: Our 2007 empirical document management study (ILSS/Gens and Associates) found the top hurdles were 1) budget, 2) network capacity and performance, and 3) vendor limitations. Interestingly, our 2009 study found 1) collaboration integration, 2) performance, and 3) improved search capability as the top priorities of change.

Our practical experience tells us that the core challenges are: 1) organizational change (business process and mindsets) and 2) how a program is constructed. Most programs grossly underestimate the people side of change as most potential users espouse or desire the new way of working, but as the project moves from concept to detailed requirements/new business processes, resistance grows. We believe that commitment to a concept is easy; however, gaining commitment to a new way of working is hard (the devil is in the details).

SwissMedic eCTD 1.0.1

It appears as thought SwissMedic will be posting an ammended version of their eCTD Guidance this week or next, likely versioned at 1.0.1.

The impact is expected to be minimal, and the agency will likely support both 1.0 and 1.0.1 revision. Early adopters will likely decide to skip 1.0.(0) and go directly 1.0.1 with vendor software support.