05.01.2012

Updates regarding EU Change Request Tracking table and Change Control Processes

Flag of EU

A new version of the EU Telematics EU eCTD Change Request/Q&A Tracking Table has been released by TIGes. The new version 1.28 of the Tracking Table contains changes from the last TIGes Joint meeting as well as changes from the Interlinking Group including classification of Change Requests (CRs) which are deferred to the next major release of the EU Module 1 specification.

Compared to the last version 1.27 from November 2011, two additional Change Requests have been added (CR 20110912-01, CR 20111010) whereas CR 20100920, CR 20110721 and CR 20110912-02 have been closed.

As regards the Q&A section, Q&A 30, 31, and 32 have been added and Q&A 28 and 29 have been closed. For details, please be referred to the EU eCTD Change Request/Q&A Tracking Table, version 1.28.


In addition, the Change Control Board has issued a Press release which gives an update on the current status of change control process and the improvements made in the past. 

The Veterinary Electronic Submission (VNeeS) Change Control Group and Change Request Process has been updated as well. A new version 1.3 from December 2011 is available for download.

[Source: EMA/TIGes eSubmission website]






<- Zurück zu: News Archiv

© 2007 - 2012 | Exalon GmbH | Fritz-Reichle-Ring 2 | 78315 Radolfzell | Germany | Phone: +49 (0)7732.939.1650 | Fax: -.1655 | e-Mail:info@exalon.com