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.

Norwegian Agency Supporting eCTD?

Google Translate Even Does Norwegian! Who needs regulatory translation services?

Seems like the Norwegian authorities are simply reiterating the EMEA drive to eSubmissions.