Abstract Deadline Extended for the DIA EDM and ERS Conference 2014

The call for session abstracts is open and the deadline has been extended to May 27, 2014. In years past, this meeting has served as a forum for peer-to-peer engagement. Attendees share their experiences and solutions to the challenges faced with electronic submissions and electronic document management within their respective organizations and working with partners and outsourcing providers. Case studies often make for compelling...

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Hyperlinking Best Practices: Common Issue in PDF Rendition
Mar25

Hyperlinking Best Practices: Common Issue in PDF Rendition

“When you use Word templates with styles and make use of the MS Word ‘cross-referencing’ option, tables, figures, sections, etc. within a given page all are automatically [linked] to their target destinations. However, when you have the same table cross referenced on the same page four (4) times, after rendition to PDF, you must manually break those three (3) extra links and convert the text from blue to black. Do you have this issue or is your EDMS customized to take care of this automatically?”

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Hyperlinking Impact on the Critical Path to eCTD Submission Deadline

This is Part 2 of a larger article on hyperlinking best practices. To read Part 1, Hyperlinking: Making the Most of Navigation in eCTD Submissions, click here.  Regulatory operations is frequently asked about submission turnaround time once the final document is delivered. The strategies around how documents are authored will often have an impact on accurately answering this question. When authors are writing submission documents and...

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Hyperlinking: Making the Most of Navigation in eCTD Submissions
Feb05

Hyperlinking: Making the Most of Navigation in eCTD Submissions

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or supportive information cited in the body of a document. There are a few industry standards with regards to hyperlinking in submissions.

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Expert Regulatory Publishing Support During Workload Peaks

There are many companies that have highly effective, small teams of regulatory operations publishers that generate eCTD submissions in-house. These small teams of publishers manage existing eCTD applications through preparing routine maintenance submissions, supplements, and small original applications with ease. However, when the workload exceeds the production capacity, the publishing manager is faced with a decision of how to...

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