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The ‘Big’ Picture of eCTD Document Navigation
The ‘Big’ Picture of eCTD Document Navigation

Our Price: $395.00

Product Code: WB-7086

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About the Product
Includes 1 hour Windows Media Video File and PowerPoint presentations for immediate download.

How Process, Perspective and People Make Measurable Impacts on Regulatory Submissions

Hyperlinks and Bookmarks play a crucial role in the navigability of various regulatory documents and submissions for agency reviewers. However, a critical analysis of the overall process, strategy, methodology, tools and vital interactions between functional groups that allows for reliable and consistent navigation is often overlooked. Poorly planned document navigation can not only create many technical issues for your submission but may lead reviewers to question the content provided within affected documents or the submission as a whole. The presenters will take a macro look at some of the best practices implemented to ensure a common understanding among key stakeholders in efforts to streamline the creation, automation, validity and accuracy of document navigation.

Craig Gassman
Senior Associate II
Biogen Idec

Michelle Petty
Associate Director of Regulatory Operations
Biogen Idec

Participants that will find this webinar most beneficial will be those involved in pharmaceutical and biotechnology companies. Job titles of attendees that will be most applicable for this session will be:

  • Medical Writers
  • Regulatory Writers
  • Regulatory Affairs
  • Regulatory Operations
  • Submissions Specialists

This webinar will be a 40 minute presentation with 20 minutes for Q&A.

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