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News Roundup Part 1: Agency News

Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account, www.twitter.com/kathie_clark.  Next time, a roundup of articles and conferences. The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting: ICH issued a new valid-values.xml for study tagging files see… Read more →

Agency News, Documents and Presentations (Recent eCTD and eSubmissions News Part 2)

As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news: CMD(h) issued a new Best Practice Guide on the use of eCTD in the MRP/DCP. Dr Martin Moxham of iRegulatory provided an excellent review of the updated CMDh best practice guide. CMDh also posted Contact E-Mail Addresses For Submission… Read more →

European Agency Roundup

There has been a lot going on at the various European agencies in the last few months.  This week, we look at some of the announcments and guidance that has been issued across Europe recently. France: – Caroline AURICHE, Philippe DÜRR and Cécile LEVY from AFSSAPS spoke at EXL Pharma, presenting on Taking the plunge from paper into electronic-only in… Read more →

Analysis: New EU M1 Spec Version 1.4

As promised, the EMEA released Version 1.4 of the EU Module 1 Specification on schedule in August.  The new spec has some changes that will impact eCTD assembly, publishing, verification and viewing software tools.  The EMEA has reached out to the vendor community to ensure that they are aware of the changes to ensure that they can modify their products… Read more →

DIA Update: eCTD in Europe (MEB and other agencies)

Rob de Haan, deputy director at MEB, spoke about the status of eCTD at MEB, and also presented a variety of EU statistics, many of them updates from the eCTD Implementation Survey Report published in December of 2008. MEB now has a full e-working environment (although they make almost no use of their eCTD viewer, for reasons Rob didn’t go… Read more →