Training Course on Building the eCTD - Practical Solutions to Compile Electronic Submissions in France

Training Course on Building the eCTD - Practical Solutions to Compile Electronic Submissions in France

For More Information Please click DIA:eCTD in France

EMA: Status Summary of EURS - April 2011

The EMA is using since November 2010 EiY release 2.8.1.52 HF6 from Extedo in production. This version of EURS has proved to be stable and no major problems have been reported since last November.

For More Information Please click  EMA:EURS

CDISC SDTM Draft Oncology Domains Open for Public Review

The Oncology Sub Team of the CDISC Submission Data Standards (SDS) Team is pleased to release three new SDTM-based domains for public review. The domains have been created with input from FDA, NCI, sponsor companies, CROs, and imaging specialists.

For More Information Please Click CDISC SDTM 

Kind Regards

Shakul.

The European Union`s struggle with electronic submissions - Michael Braun

It is hard to be an eSubmission enthusiast when you live – and work - in the EU nowadays. It is not only because the eCTD still is making it very slowly into standard submission practice even in big pharma. It is also because the reason for that is very obvious – there are no clear commitments from the EU national drug regulatory agencies to further mandate the standard. Instead, we are now maintaining two separate standards, the eCTD and the NeeS. Initially invented as a short-term interim standard to further drive the change from paper to eCTD, the NeeS proved itself astoundingly popular and robust against any intentions to retire it.  Unfortunately it does not provide any structured metadata and more important any life-cycle features. Well, this is what must be accepted by now.

For More Information Please Click EU eSubmissions Michael Braun 

Regards

Shakul.

Updated EU CMD(h) Contact Addresses for Various Submissions and Applications.

Updated EU CMD(h) Contact Addresses for Various Submissions and Applications.

For More Information Please click EU CMD(h) 

Kind Regards

Shakul

FDA CVM : Launches eSubmitter Tool for Veterinary Products Submissions

The Food and Drug Administration's eSubmitter tool is part of an electronic submissions program for a variety of submission types. The tool was made available for voluntary use by sponsors, and manufacturers in the animal health industry on March 11, 2011, for submissions to the Office of New Animal Drug Evaluation (ONADE). With completion of ONADE's rollout, additional submission types from other offices within CVM (Office of Surveillance and Compliance and Office of Minor Use and Minor Species) will become available. The eSubmitter program is a free program that is designed to minimize redundant data entry while collecting data in a structured format.

For More Information Click FDA CVM: eSubmissions

Regards

Shakul.