About the Webinar

Are you tired of spending countless hours formatting and styling your submission documents? Do you want to learn how to speed up your content preparation process and ensure compliance with regulatory agency requirements? Join us on March 30th at 13:00 BST for a free webinar, called “How to Accelerate Submission Content Preparation”, where industry experts will share their insights on the latest strategies for preparing submission content efficiently. The webinar will cover topics such as creating submission-ready, consistently formatted MS Word documents, using custom styles versus templates, troubleshooting tricky formatting, and organizing documents more efficiently.

The webinar covers 

How can your company ensure that:
• authors can focus on the content, rather than formatting & styling?
• document quality specialists can:
  -lessen the risk associated with manual processes?
  -reduce the time spent on documents quality check?

How can authors:
• ensure that their documents meet the technical specification requirements?
• ensure that section numbering is sequential, headings are used appropriately, tables are formatted correctly, approved fonts are used?
• use custom styles versus templates?
• troubleshoot tricky formatting?
• organize documents more efficiently?
• create a Word document that will produce a PDF file that is over 95% compliant?

How can quality managers easily check and fix:
• bookmarks and hyperlinks and external weblinks?
• page layout and margins in every section?
• hidden parts and instructions?
• placeholders and special formatting (e.g., blue text)?

Well organized and consistently formatted documents are the key to creating submissions that are easy to read and review.
Prior to submission, organizations spend a significant amount of time making sure that these and other aspects of their content are in order.

Even though it is impossible to completely eliminate manual steps, cutting them down can speed up your process and lower the risk of human error. Many of the checks and fixes that are currently done manually, both for your original source Word content and for your submission-ready PDFs, can be fully automated.

What will you Learn?

In addition, the webinar will explain how you can speed up content preparation processes for your submissions and give useful tips for creating submission-ready, consistently formatted MS Word documents. You’ll learn how to validate Word and PDF files much faster, how to effectively create and insert table/figure/captions and hyperlinked internal links, how annoying formatting problems can be located and fixed without using a magnifier, how many of your authoring checks and fixes can be fully automated with emerging technology, how to update your documents to a new standard in a few steps, and how to perfect the abbreviation table or even create it from scratch.

Who is this Webinar for?

Our webinar is perfect for technical and clinical authors and regulatory medical writers, submission documentation leads, clinical document management leads, regulatory operations professionals, regulatory document specialists, clinical document management experts, document quality managers, document quality analysts, document administrators, By attending, you will gain valuable insights that will help you ensure that your documents meet technical specification requirements and reduce the time spent on documents quality check.

The Experts Presenting

Don’t miss out on the opportunity to learn from industry experts Zsuzsa Fülöp, Senior Business Analyst, and Zoltán Kovács, Solution Delivery Manager. Both have more than 20 years of experience in life science document management and have contributed to the development of solutions for managing life sciences documents.

Zsuzsa Fülöp, Senior Business Analyst
For more than 20 years, Zsuzsa has worked as a business analyst on projects involving life science document management.
She is currently taking business requirements into account as OnStyle, DACHS’s solution to Word formatting problems, is being developed.
She has an MSc in Mathematics. She has a solid technical foundation and an outstanding customer-centric attitude.

Zoltán Kovács, Solution Delivery Manager
Zoltán is a specialist in submission-related Word formatting issues and their fixes, with more than 20 years of experience in a variety of IT roles and more than 10 years of experience in developing solutions for managing life sciences documents.
He contributed to Microsoft Office Macro development and the creation of integrations and add-ons to PleaseReview and OpenText Documentum D2.
He is currently in charge of the ongoing development of OnStyle, DACHS’s answer to Word formatting issues.
He has a BSc in Electrical engineering, an MSc in Information engineering, and a BSc in Economics engineering. The recent, successful projects are evidence of his professional background and top-notch customer management abilities.

How to Register?

Register now for the “How to Accelerate Submission Content Preparation” webinar and start creating submission documents that are easy to read and review. With the help of emerging technology and the latest strategies, you can speed up your content preparation process and ensure compliance with regulatory agency requirements.

Registration Link: https://www.topra.org/TOPRA/TOPRA_Member/Events/Event_Display.aspx?EventKey=SPOWEBDA23

Sources

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17/03/2023