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	<title>The eCTD summit</title>
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	<pubDate>Wed, 18 Aug 2010 14:56:26 +0000</pubDate>
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		<title>eCTD News Roundup: Online Articles, Standards News, and Conferences</title>
		<link>http://theectdsummit.com/summit/?p=858</link>
		<comments>http://theectdsummit.com/summit/?p=858#comments</comments>
		<pubDate>Wed, 18 Aug 2010 03:20:19 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[Conference]]></category>

		<category><![CDATA[Labeling]]></category>

		<category><![CDATA[PDFs]]></category>

		<category><![CDATA[Regulated Product Submissions (RPS)]]></category>

		<category><![CDATA[eCTD Best Practices]]></category>

		<category><![CDATA[eCTD Quality]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=858</guid>
		<description><![CDATA[A number of good articles related to eSubmissions have been posted online recently.  Below, a recap based on posts from my twitter account, www.twitter.com/kathie_clark.  


Even Richardson of Cato Research posted a useful blog entry, Bookmarks – Collapsed or Expanded? On the “Ask Cato” blog.  The entry discusses the FDA reviewers’ preferences for the default expansion [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=858</wfw:commentRss>
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		<item>
		<title>News Roundup Part 1: Agency News</title>
		<link>http://theectdsummit.com/summit/?p=854</link>
		<comments>http://theectdsummit.com/summit/?p=854#comments</comments>
		<pubDate>Thu, 12 Aug 2010 15:32:29 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[EMEA]]></category>

		<category><![CDATA[Global Regulatory Agencies]]></category>

		<category><![CDATA[ICH]]></category>

		<category><![CDATA[NeeS]]></category>

		<category><![CDATA[PIM]]></category>

		<category><![CDATA[Specifications]]></category>

		<category><![CDATA[Swissmedic]]></category>

		<category><![CDATA[TGA]]></category>

		<category><![CDATA[U.S. FDA]]></category>

		<category><![CDATA[eCTD Validation]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=854</guid>
		<description><![CDATA[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 [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=854</wfw:commentRss>
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		<item>
		<title>21 CFR Part 11 and Electronic Publishing: the Elephant in the Room?</title>
		<link>http://theectdsummit.com/summit/?p=851</link>
		<comments>http://theectdsummit.com/summit/?p=851#comments</comments>
		<pubDate>Fri, 23 Jul 2010 15:16:33 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[EDMS]]></category>

		<category><![CDATA[Electronic Publishing]]></category>

		<category><![CDATA[Guidance]]></category>

		<category><![CDATA[U.S. FDA]]></category>

		<category><![CDATA[eCTD Best Practices]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=851</guid>
		<description><![CDATA[In my document management career, my company provided specialized EDMS solutions for Pharma (for submissions, SOPs, trial master files, etc.).  It was a given that these systems needed to be Part 11 compliant, and I authored our position paper on how Part 11 compliance was achieved and demonstrated in our product.  If our product had [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=851</wfw:commentRss>
		</item>
		<item>
		<title>Update to Study Tagging File valid-values: What Does It Mean?</title>
		<link>http://theectdsummit.com/summit/?p=841</link>
		<comments>http://theectdsummit.com/summit/?p=841#comments</comments>
		<pubDate>Mon, 19 Jul 2010 13:01:24 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[ICH]]></category>

		<category><![CDATA[Specifications]]></category>

		<category><![CDATA[Study Tagging Files]]></category>

		<category><![CDATA[U.S. FDA]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=841</guid>
		<description><![CDATA[As I discussed in my previous post, FDA issued version 1.5.1 of Study Data Specifications in January of 2010.  Although the changes in the new version were not great, they were significant for eCTD as a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=841</wfw:commentRss>
		</item>
		<item>
		<title>FDA Reviewer Survey: CTD/eCTD Quality</title>
		<link>http://theectdsummit.com/summit/?p=836</link>
		<comments>http://theectdsummit.com/summit/?p=836#comments</comments>
		<pubDate>Mon, 28 Jun 2010 12:27:34 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[CTD]]></category>

		<category><![CDATA[Conference]]></category>

		<category><![CDATA[DIA]]></category>

		<category><![CDATA[PDFs]]></category>

		<category><![CDATA[Refuse to File]]></category>

		<category><![CDATA[U.S. FDA]]></category>

		<category><![CDATA[eCTD Best Practices]]></category>

		<category><![CDATA[eCTD Quality]]></category>

		<category><![CDATA[eCTD Review]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=836</guid>
		<description><![CDATA[Dr. Sarah Connelly, FDA clinical reviewer and Medical Officer, Division of Antiviral Products, presented some interesting and useful survey results at the DIA Annual Meeting on June 16th.  The survey gathered information on FDA reviewers’ perception of submission quality in a number of specific areas.  It was a collaboration between FDA and the DIA Medical [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=836</wfw:commentRss>
		</item>
		<item>
		<title>What is a porp?  How RPS XML is different (and scarier) than eCTD</title>
		<link>http://theectdsummit.com/summit/?p=828</link>
		<comments>http://theectdsummit.com/summit/?p=828#comments</comments>
		<pubDate>Thu, 27 May 2010 12:54:53 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[Regulated Product Submissions (RPS)]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=828</guid>
		<description><![CDATA[Recently, I was providing some training to a GlobalSubmit client and one of the participants asked me about an xml document that was present in a folder along with the sample eCTD that we use for training.  The document was called “porp.xml”.  I explained that GlobalSubmit’s VALIDATE product can transform eCTD into RPS and when [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=828</wfw:commentRss>
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		<item>
		<title>Top FDA Processing Issues with eCTD: A Recent Update</title>
		<link>http://theectdsummit.com/summit/?p=806</link>
		<comments>http://theectdsummit.com/summit/?p=806#comments</comments>
		<pubDate>Wed, 19 May 2010 03:15:37 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[ANDA]]></category>

		<category><![CDATA[Technical Rejection]]></category>

		<category><![CDATA[U.S. FDA]]></category>

		<category><![CDATA[eCTD Best Practices]]></category>

		<category><![CDATA[eCTD Quality]]></category>

		<category><![CDATA[eCTD Review]]></category>

		<category><![CDATA[eCTD Validation]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=806</guid>
		<description><![CDATA[At a  GPhA/FDA Labeling Workshop on April 14, 2010, Virginia Ventura of CDER&#8217;s Office of Business Informatics presented CDER Update eCTD &#38; Gateway Submissions.  Along with lots of other useful information, Ms. Ventura provided an assessment of the current Top Processing Issues with Esubs:




Description


Percent of total




Unable to extract info from PDF form (sponsor did not [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=806</wfw:commentRss>
		</item>
		<item>
		<title>Advanced eCTD and the Educated Sponsor</title>
		<link>http://theectdsummit.com/summit/?p=797</link>
		<comments>http://theectdsummit.com/summit/?p=797#comments</comments>
		<pubDate>Mon, 10 May 2010 13:31:08 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[Regulated Product Submissions (RPS)]]></category>

		<category><![CDATA[eCTD Best Practices]]></category>

		<category><![CDATA[eCTD Quality]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=797</guid>
		<description><![CDATA[This week’s blog posting is from Rahul Mistry, CEO of GlobalSubmit, who recently was a featured speaker at the RAPS workshop entitled &#8220;Advance eCTD Submissions&#8221;.  Rahul&#8217;s presentation focused on eCTD quality, a topic that obviously interested the audience based on the significant number of questions that he received.    
Two weeks ago I had the pleasure at [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=797</wfw:commentRss>
		</item>
		<item>
		<title>Updated Study Data Specifications and the eCTD Dataset Problem</title>
		<link>http://theectdsummit.com/summit/?p=788</link>
		<comments>http://theectdsummit.com/summit/?p=788#comments</comments>
		<pubDate>Thu, 29 Apr 2010 19:12:52 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[Electronic Publishing]]></category>

		<category><![CDATA[Specifications]]></category>

		<category><![CDATA[U.S. FDA]]></category>

		<category><![CDATA[eCTD Best Practices]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=788</guid>
		<description><![CDATA[A few months ago, FDA issued version 1.5.1 of Study Data Specifications.  Although the changes in the new version were not great, they were significant for eCTD as a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=788</wfw:commentRss>
		</item>
		<item>
		<title>Advice from Evan Richardson, Cato Director of Reg Ops, for Sponsors New to eCTD</title>
		<link>http://theectdsummit.com/summit/?p=777</link>
		<comments>http://theectdsummit.com/summit/?p=777#comments</comments>
		<pubDate>Mon, 19 Apr 2010 12:39:12 +0000</pubDate>
		<dc:creator>Kathie Clark</dc:creator>
		
		<category><![CDATA[U.S. FDA]]></category>

		<category><![CDATA[eCTD Best Practices]]></category>

		<category><![CDATA[eCTD Quality]]></category>

		<category><![CDATA[eCTD Readiness]]></category>

		<category><![CDATA[eCTD Review]]></category>

		<guid isPermaLink="false">http://theectdsummit.com/summit/?p=777</guid>
		<description><![CDATA[I often work with the Regulatory Operations department at Cato Research and I’m always impressed by the depth and breadth of their knowledge.  Cato creates submissions for such a wide cross-section of the sponsor community that their associates have truly “seen it all”, and they can cite a precedent and define a best practice in [...]]]></description>
		<wfw:commentRss>http://theectdsummit.com/summit/?feed=rss2&amp;p=777</wfw:commentRss>
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