eCTD Publishing Best Practices
Mar09

eCTD Publishing Best Practices

People seeking advice on eCTD publishing best practices usually fall into one of two groups: (1) Sponsors who are new to eCTD, for example, medical writers or project managers (2) eCTD publishers. The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions.

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Collection of eCTD Online News, Part 2

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 of PDF bookmarks. Pharma IQ shared the results of their recent poll, “Do...

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Advice for Sponsors New to eCTD

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 response to almost any question they are asked. Recently, I took advantage of an opportunity to interview...

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Final Health Canada eCTD Guidance Addresses Naming Conventions, Lifecycle Operations

Health Canada has posted a final version of Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format on their web site. This version, dated November 4, 2009, replaces the draft version dated January 25, 2006. On the whole, the changes are more evolutionary than revolutionary. Throughout the document, the previous terminology of “Annual update forms summarizing the Notices of Change”...

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