The eCTD Summit

tag:blogger.com,1999:blog-80399953779306812842011-06-08T02:34:11.350-04:00The eCTD SummitThe eCTD Summit is a forum for the exchange of ideas and information relating to the electronic Common Technical Document (eCTD). This blog is sponsored by GlobalSubmit but is intended to broaden the discussion relating to the adoption and implementation of the eCTD.Kathie Clarknoreply@blogger.comBlogger291100tag:blogger.com,1999:blog-8039995377930681284.post-62011026226763132672009-01-23T08:47:00.003-05:002009-02-03T09:52:44.250-05:00The eCTD Summit is moving!

We are re-locating The eCTD Summit to a new location that will allow us to provide additional content such as RSS feeds, upcoming events and more.From now on, no new posts will appear on this site. New posts will appear on:http://theectdsummit.com/summit/Please visit us there, bookmark the page, and sign up for an RSS feed so you will be automatically notified of new posts!Kathie

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-36959285660248845152009-01-20T14:24:00.001-05:002009-01-21T12:51:33.305-05:00FDA to begin rejecting eCTDs for significant technical issues

Due to the increased adoption of the eCTD and number of submissions received by the U.S. FDA, submission quality is receiving increased focus and attention at the U.S. FDA. In recent conversations with FDA officials, they have expressed a commitment to increase their diligence and oversight with respect to submission quality and have signaled their intention to begin rejecting eCTD sequences

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-74383870795843896872009-01-09T11:45:00.013-05:002009-01-16T17:47:38.856-05:00Goodby NeeS!

Sounds like EMEA stayed busy through the holiday season as they posted four new or updated guidance documents at the end of December. Most significantly, EMEA implementation of electronic-only submissions and mandatory eCTD submissions in the centralised procedure: Statement of Intent tells us:"From 1 January 2010, the EMEA will mandate the use of the eCTD format for all electronic-only

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-26839156124050781342008-12-29T16:56:00.014-05:002008-12-30T08:48:40.710-05:00More news and updates from the EU agencies

As the EU authorities continue their progress towards welcoming eSubmissions, information continues to surface on their web sites and elsewhere.The Swedish National Authority (MPA) has updated their web site with new eSubmission information - see Electronic submissions to the MPA. The MPA maintains a dedicated email address (eSubmissions@mpa.se) for general questions on electronic submissions.

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-84562644624520230872008-11-25T12:19:00.007-05:002008-12-03T20:38:41.438-05:00How's Your Italian??

I'm honored to have been referenced on a new Italian eCTD web site, the eCTD.it User Group. The site references a post of mine about Gary Gensinger's remarks at DIA on a page called eCTD: The Quality of the Dossier:http://www.ectd.it/knowledge/introduzioni/77-ectd-la-qualita-del-dossier Fortunately, my ability to read and speak Italian like a native served me well here... Just kidding ;-)But

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-40704071448579287972008-11-25T09:21:00.008-05:002008-11-25T09:58:20.219-05:00Common eCTD Mistakes - as Described by FDA (Part 2)

Continued from last time... Notes from my discussion with Virginia Ventura.Virginia mentioned lack of a cover letter, or lack of a useful cover letter, as a significant issue. Although the cover letter is not a regulatory requirement, it serves as the reviewers' "Road Map" to the submission, and Virginia can't understand why a sponsor would not take advantage of the opportunity to provide clarity

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-17778092931263234862008-11-07T13:22:00.000-05:002008-11-10T09:22:52.425-05:00Common eCTD Mistakes - as Described by FDA

I recently had a great chance to talk to Virginia Ventura of FDA's Electronic Submission Support Team about the common mistakes made by sponsors in preparing eCTDs. Virginia told me that mistakes are not confined to small or inexperienced companies. In many cases, these errors result from a lack of basic QC. Here are some examples:Not updating documents that were created based on templates

Kathie Clarknoreply@blogger.com1tag:blogger.com,1999:blog-8039995377930681284.post-54275298670189860202008-10-10T09:17:00.000-04:002008-10-14T14:47:54.911-04:00eCTD on the Agenda at Upcoming ICH Meeting

A public ICH meeting is planned for 14 November 2008 in Brussels, Belgium. See Brussels ICH Public Meeting, Nov. 14, 2008 for the details and agenda.The agenda includes a session on standards development for the electronic exchange of information (chaired by Andrew Marr). That session will include, among other topics, an update on eCTD from Joe Cipollina.

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-80028897177232636912008-10-04T09:32:00.000-04:002008-10-06T15:01:10.760-04:00RPS 2 Vancouver Working Group Meeting

An RPS2 Working Group meeting was held in Vancouver the week of September 15.The working group discussed a number of business scenarios including:Two Way Communication – Pre-Submission CorrespondenceSubmission Activities – Request Submission NumberSubmission Activities – Meeting Request and ResponsesNotification of Decision or ActionRequest/Response for Additional information during a review

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-51148226978686019262008-09-24T11:37:00.000-04:002008-09-24T11:50:49.377-04:00Still time to sign up for webinars

It's not too late to sign up for the two remaining entries in GlobalSubmit's 2008 Executive Webinar Series: Mastering the eCTD.This series has been very well received to date and has covered topics such as: Mastering eCTD operatorsBest practices in submission reviewingIntroduction To Regulated Product Submissions (RPS)Scanned Input PreparationUnderstanding Regional DifferenceseCTD File FormatsThe

Kathie Clarknoreply@blogger.com1tag:blogger.com,1999:blog-8039995377930681284.post-40351992435752285032008-09-16T11:14:00.000-04:002008-09-16T11:36:25.211-04:00ICH Publishes Updates to eCTD Specification

ICH has published a new eCTD specification (version 3.2.2) and STF specification (v2.6.1), as promised some time ago. This was done with little fanfare - the announcement and links to the documents can be seen at:eCTD NewsFor those of you who monitor What's New on the ICH website? - the updates did not merit a mention there.The changes resulted from a June meeting, the documents are dated July

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-54710793001911272992008-09-02T10:42:00.000-04:002008-09-08T09:41:24.335-04:00RPS has a wiki!

Regulated Product Submissions (RPS) now has a Wiki (or more accurately, it's part of the overall HL7 Wiki).To get there, go to Main Page HL7 Wiki. You will have to log in, but you can use the following credentials for read only access:user name: wikipassword: wikiwiki(You must create a user name and password if you want to contribute.)Once you get there, click on the Regulated Product

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-83359254391136834342008-09-01T09:42:00.001-04:002009-01-14T16:02:08.150-05:00Cross Application Links in eCTD

A little while ago, a client asked me about referencing documents submitted in one application from another application. Her question was in the context of an IND and an NDA, both submitted in eCTD format - did she have to re-submit documents in her NDA that had already been submitted in her IND?The ICH guidance is basically silent on this subject, although the structure does not specifically

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-16556374289012756522008-08-20T16:32:00.000-04:002008-08-21T13:48:14.680-04:00Anyone notice Updated EMEA Documents posted?

If you visit the EMEA eSubmission: What's new page, you will see that several new documents have been posted (date says July 27th, but I think it was really after that...).The updated documents are: Updated EU Telematics EU eCTD Change Request/Q&A Tracking Table EU Validation Criteria v2.0 EA Practical/Technical Q&A on eCTD Submission V0.4Updates to the CR/Q&AThese updates are mainly in support

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-61681486454533665092008-08-20T14:40:00.001-04:002008-08-20T14:41:51.541-04:00You can subscribe to this blog

Did you know that you can subscribe to this blog as an RSS feed so you don't have to keep checking back to see if anything is new?Just click on the link at the bottom of the page:Subscribe to: Posts (Atom)

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-44752284435585915072008-08-12T09:41:00.000-04:002008-08-12T10:19:05.267-04:00RPS 2 News

On July 24th, 2008, a kickoff meeting was held at FDA's Whiteoak facility for Regulated Product Submission (RPS) Version 2. For those of you who have not been following RPS, it is a Health Level Seven (HL7) standard to facilitate the processing and review of regulated product information. The goal of RPS is to create a regulated product submission message that:Is general enough to handle all

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-88854329046532343662008-08-08T15:14:00.000-04:002008-08-08T15:27:00.646-04:00Improved and Reorganized iRegulatory eCTD resource pages

Many of you have probably benefited from the "eCTD Resource Page" in the past. For both previous and new users, there's some good news - the site iRegulatory eCTD resource pages has been updated and expanded.The site features basic background, links to regualatory agencies, vendors and other eCTD resource pages, and a discussion forum for posting comments or questions. It's a great opportunity

Kathie Clarknoreply@blogger.com1tag:blogger.com,1999:blog-8039995377930681284.post-29760458451857241702008-07-15T09:54:00.001-04:002008-07-18T03:51:37.026-04:00Submit Documents With Tracked Changes?

Recently, I have come across several instances where applicants or regulators have discussed submitting documents with tracked changes. Clearly, there is some guidance for this in the area of EU and US labeling, but this was the first that I had heard of it potentially being done elsewhere in a dossier.The first was at DIA, where Norman Schuff of the FDA recommended submitting Module 3

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-7594127206401428632008-07-15T09:24:00.000-04:002008-07-17T03:11:41.902-04:00What's New in EU Module 1 Specification Version 1.3 (May 2008)

Europe recently made some fairly significant changes to eCTD Module 1 Guidance. You can see and download the specification, release notes, examples, and overall package at: http://esubmission.emea.europa.eu/eumodule1/. Look for an update from your publishing vendor as DTD and publishing tool changes are needed to support the new spec - and remember that EMEA has said that they require compliance

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-39879848546218434152008-07-15T05:16:00.000-04:002008-07-15T05:24:15.524-04:00Changes to CTD Guidance in Europe

Recently, a new edition of “Volume 2B Notice to Applicants: Medicinal products for human use: Presentation and format of the dossier Common Technical Document (CTD)”, Edition May 2008 (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/update_200805/ctd_05-2008.pdf) was posted on EudraLex. This replaces the June 2006 edition.In addition to updates and correction of references, the

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-45868567968806166372008-07-10T09:07:00.000-04:002008-07-10T09:53:21.755-04:00Update to FDA Guidance

On June 11th, 2008, FDA issued a Revision 2 of "Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" (http://www.fda.gov/cder/guidance/7087rev2.pdf). The previous version, Revision 1, dated from April 2006.So what's new? Very little.The updates are all administrative in nature, and basically

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-61169995826719365122008-07-07T09:23:00.000-04:002008-07-09T09:51:31.048-04:00EMEA and PMDA Update at DIA

EMEA and PMDA provided an update on eCTD status at the traditional "Update on Regulatory Authority Experience" session.Tim Buxton was the speaker from EMEA. He provided the following statistics on eCTDs received between July and December 2007: Centralised Procedure: 14 new applications, 80 variations National Procedures (as reported by national compentent authorities): 659 new applications, 611

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-21260763797972318982008-06-30T17:23:00.000-04:002008-07-09T09:52:10.352-04:00Some news from the regulators

I attended a session at the DIA annual meeting where the regulators spoke about the status of eCTD in their regions. I'll give some updates from EU and Japan in my next post; today's post focuses on FDA updates.Gary Gensinger gave the US eSubmission update. The most interesting point that Gary made was in the "myth busting" department. Gary told us "There is no advantage to submitting in paper

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-30631099830267222682008-06-30T08:14:00.000-04:002008-06-30T08:16:11.230-04:00Up and Running!

To all who have had a look at this blog and were interested, but disappointed to see that there were no recent posts - we started the blog some time ago but experienced some delays in posting to search engines. We're up and running now, and I will be blogging in the near future about updated guidance issued by FDA and EMEA, some interesting news from the recent DIA annual meeting in Boston, and

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-84712629061788899822008-02-08T15:42:00.000-05:002008-07-09T09:52:40.022-04:00What's New with eCTD in Japan?

eCTD readiness in Japan has always been more challenging than in other regions due to issues with tools handling Kanji characters among other reasons. However, Kiyohito Nakai,Priority Review Director at PMDA, was able to report substantial progress in a February 7th presentation at the DIA Doc Management conference in Philadelphia.To date, Japan has received a relatively small number of eCTDs. To

Kathie Clarknoreply@blogger.com1tag:blogger.com,1999:blog-8039995377930681284.post-58616066364009328392008-02-05T19:01:00.000-05:002008-07-09T09:53:08.121-04:00ICH M2 (ESTRI) EWG will not implement eCTD 3.3.3

At the October 2007 ICH Meeting of the ICH, the decision was taken by the ICH M2 (ESTRI) EWG with approval from the ICH Steering Committee to stop the progression of the eCTD Version 3.3.3 Step 2 for Testing. The reason given was to focus on gathering the business requirements for the next major version of the eCTD.In general, the changes proposed in Version 3.3.3 were more beneficial to industry

Kathie Clarknoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-42891917068763541392008-02-05T14:57:00.000-05:002008-07-09T09:53:25.187-04:00EMEA Announces Statement of Intent Regarding eCTD and eSubmissions

EMEA has reinforced its position on implementing the electronic-only submission of information in support of marketing authorisation applications in the centralised procedure, and, ultimately, implementation of the Electronic Common Technical Document (eCTD) as the required format for electronic submissions, in two new documents dated 22 January 2008:EMEA implementation of electronic-only

Kathie Clarknoreply@blogger.com1tag:blogger.com,1999:blog-8039995377930681284.post-74317691139784120312008-02-02T19:11:00.000-05:002008-02-02T19:18:19.908-05:00eCTD Study Tagging Files - What Exactly Is Required?

One of the most challenging, or dare I say confusing aspects of the eCTD is the organization and structure of the Study Tagging Files (STFs). Many ask the question "what exactly is required for STFs? The quick answer is clarity. The FDA requires a logicial organization to be able to determine which files belong with which study. The more logicial you can arrange them, the better off your

The eCTD Masternoreply@blogger.com0tag:blogger.com,1999:blog-8039995377930681284.post-71948596431683725782008-02-02T19:04:00.000-05:002008-02-02T19:08:11.730-05:00Welcome To The eCTD Summit!

To all those within the life sciences community, GlobalSubmit welcomes you to The eCTD Summit blog. The purpose of this blog is to provide a forum for the exchange of ideas, trends, and best practices around the adoption and implementation of the eCTD. It is our intent to eliminate any marketing from this blog and focus on practical ideas beneficial to the community at large. We hope you

The eCTD Masternoreply@blogger.com0