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The eCTD Summit

Friday, January 23, 2009. The 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:. Please visit us there, bookmark the page, and sign up for an RSS feed so you will be automatically notified of new posts! Posted by Kathie Clark. Links to this post. Tuesday, January 20, 2009. What are Significant Technical Issues?

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Friday, January 23, 2009. The 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:. Please visit us there, bookmark the page, and sign up for an RSS feed so you will be automatically notified of new posts! Posted by Kathie Clark. Links to this post. Tuesday, January 20, 2009. What are Significant Technical Issues?

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The eCTD Summit | theectdsummit.blogspot.com Reviews

https://theectdsummit.blogspot.com

Friday, January 23, 2009. The 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:. Please visit us there, bookmark the page, and sign up for an RSS feed so you will be automatically notified of new posts! Posted by Kathie Clark. Links to this post. Tuesday, January 20, 2009. What are Significant Technical Issues?

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theectdsummit.blogspot.com

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The eCTD Summit: February 2008

http://theectdsummit.blogspot.com/2008_02_01_archive.html

Friday, February 8, 2008. What'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 date, they have received:. Posted by Kathie Clark.

2

The eCTD Summit: FDA to begin rejecting eCTDs for significant technical issues

http://theectdsummit.blogspot.com/2008/12/fda-to-begin-rejecting-ectds-for.html

Tuesday, January 20, 2009. FDA 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. On November 18 th. DRAFT, Decemb...

3

The eCTD Summit: June 2008

http://theectdsummit.blogspot.com/2008_06_01_archive.html

Monday, June 30, 2008. Some 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 listed the advantages of eCTD as seen by FDA as:. Supporting a better, more comprehensive review. Providing for a more efficient and effective review process. Posted by Kathie Clark. Links to this post. Posted by Kathie Clark.

4

The eCTD Summit: October 2008

http://theectdsummit.blogspot.com/2008_10_01_archive.html

Friday, October 10, 2008. ECTD 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. Posted by Kathie Clark. Links to this post. Saturday, October 4, 2008. What top...

5

The eCTD Summit: Goodby NeeS!

http://theectdsummit.blogspot.com/2009/01/goodby-nees.html

Friday, January 9, 2009. 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. As with the rest of the EMEA's statements and guidelines pertaining to eCTD, this only applies to the Centralised Procedure. A "matching" statement of intent for non-eCTD electronic submissions.

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The eCTD Summit

Friday, January 23, 2009. The 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:. Please visit us there, bookmark the page, and sign up for an RSS feed so you will be automatically notified of new posts! Posted by Kathie Clark. Links to this post. Tuesday, January 20, 2009. What are Significant Technical Issues?

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