Wakey, wakey...

Greetings faithful readers, and I do mean faithful if you have been reading the blog consistently despite the lack of regular updates. I've been quite busy with Real Life and Day Job and sadly have not been keeping up with you out here on the Web. A lot has changed since last I wrote you, but I trust that the wonderful world of eSubmissions has been keeping you quite busy. A quick recap of things that have happened since we last spoke:

• SwissMedic has revised their eCTD spec again (yes, already): CH 1.1 eCTD
• The Japanese agency has suggested that sponsors include additional sections in the JP M1 (a new section per each "additive" or excipient)
• ICH has updated the STF Valid Values specification (v3.0)...
• ...which is clearly intended to support the updated FDA guidance on organizing datasets (basically putting tabulations into two folders -- one for sdtm datasets, one for "legacy" non-sdtm dataset -- take a look at the mockup on page 8).
  
• The rumor is that the timeline for implementation will be next year, coinciding with an FDA review system upgrade, but that has not been confirmed on the agency's website as of this writing. The may be an FDA M1 specification update in the works around that time, but this is still speculation.
• Croatia put out an eCTD specification. Finding this is difficult since vendor press releases seem to be easier to get at than the specification itself.
  
• RPS (the eCTD successor) has had some activity amongst the testing team, but is still a bit away from a workable specification for industry...or that's some people's opinion. :)

I thank you all for continuing to endorse this site. I have to admit I get some smug satisfaction every time eCTDBlog.com comes up high on the list of Google results. Twice as much if eCTDBlog.com is above the regulator's site.

Good luck with the end of year rush, and be kind to your sofware vendors!

ETICS III Starting Up

The good people of the IRISS Forum are gearing up for ETICS III initiative. Having participated in this initiative in the past, it has always been proven to be beneficial. One open question I personally would love to see addressed is a "preferred" approach to eCTD section 3.2.A which is notoriously left up to the applicant to define and as a result still see quite a lot of variance across tools.

Creating eSub Compliant PDFs with Newer Version of Acrobat

Place in the "I wish I had a dollar for every time I heard this one" file.

Great post around creating compliant PDFs direclty with newer versions of Acrobat, from Rick Borstein at Adobe:

http://blogs.adobe.com/acrobatforlifesciences/2010/01/can_new_versions_of_acrobat_cr.html

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.

EMEA Posts Veterinary eSubmission Guidelines

The EMEA recently posted their guidance on Veterinary eSubmissions, v1.1, called the "VNeeS". In general this guidance suggests that you use a folder structure similar to the methods used in existing NeeS submissions, but corresponding to 4 parts instead of the 5 modules of an eCTD.

Additionally, one global PDF-based TOC (GTOC) should be created to allow navigation of the entire dossier, and 4 TOCs for each of the 4 parts. One subtle difference is that it appears that the global TOC should refer to all sub-documents, not just the individual part-TOCs (a subtle difference from the NeeS Guidance).

All in all, this should be relatively easily met by most modern publishing systems capable of delivering a NeeS.

This also sets an interesting precedent as in Europe its a candidate for one of the first non-eCTD eSubmission formats and helps build a future case for the ubiquity of RPS.