Cover Image for Lessons Learned on Document Preparation in Life Sciences (Abstract from the DIA Regulatory Submissions, Information and Document Management Forum 2022)

Lessons Learned on Document Preparation in Life Sciences (Abstract from the DIA Regulatory Submissions, Information and Document Management Forum 2022)

Hosted by Geert Van Peteghem & Paul Ireland - VP Life Sciences
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About Event

Regulatory submissions are one of the most critical milestones for Life Sciences organizations. Submitting on time & in full compliance with regulatory agencies' requirements, remains a challenge. Life Sciences organizations adopt cutting-edge technology, but the technology alone doesn't guarantee compliance & that timelines are met. Efficient processes combined with technology does.  

This webinar outlines how organizations can streamline content preparation processes for their submission documents.

Regulatory submissions can consist of thousands of documents. These are authored, reviewed, updated & formatted in tools like MS Word to strict guidelines before inclusion in dossiers. Multiple groups are involved in ensuring they meet the technical requirements, so how can you make sure that:

  • Medical Writers & other authors can focus on the content, rather than formatting & styling? 

  • Reg. Ops. can reduce the time needed to rework externally authored documents & achieve content compliance earlier, with less risk from manual steps?

Ensuring section numbering is sequential, web links aren’t included, headings are used appropriately, tables are formatted correctly, approved fonts are used, hyperlinks have targets & are colored correctly in MS Word documents. Checking bookmarks & hyperlinks have the correct zoom level, initial page view is as expected, file is optimized & doesn’t exceed size limits in PDF content. Organizations spend a huge amount of time ensuring that these & other aspects of their content are in order prior to submission.

It is impossible to eliminate all manual steps but reducing these by a significant amount can speed up your QC process & reduce the risk from human error.

During our presentation on August 26th, we will explain how such a reduction in manual steps can be achieved. It is possible to fully automate many of the checks & fixes performed manually or in batch today; both on your original source Word content & on your submission-ready PDFs. 

Learning Objectives

After following this 30-minute session, you will be able to: 

  1. Understand that many of your authoring checks and fixes can be fully automated with emerging technology.

  2. Understand that automating the validation of PDF files against Health Authority guidelines is possible much earlier in the process, and can save time and reduce the risk of non-compliance 

  3. Walk away with practical tips on how rendering technology can help streamline regulatory submission processes

  4. Get a clear understanding of the additional benefits fully automated processes provide over batch processing.