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Loews Royal Pacific Resort at Universal Orlando Resort

Mar 21, 2022 7:00 AM - Mar 23, 2022 5:00 PM

6300 Hollywood Way, Orlando, FL 32819

Medical Affairs and Scientific Communications Forum

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!

Session 5 Track 2: Lean Authoring and Global CTD Submission

Session Chair(s)

David  Meats

David Meats

Director, Regulatory Services Management

Certara, United States

In this session, participants will learn the key tenets of the lean authoring methodology and process. In addition, attendees will learn how to apply these techniques to simplify and shorten the length of certain components of an eCTD submission. These taken in tandem can reduce the complexity, length, and potential for error.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify the key tenets of the lean authoring methodology and process
  • Apply these tenets to an eCTD submission
  • Identify the positives and challenges to this type of regulatory writing style


Elizabeth  Brown, MS, PMP


Elizabeth Brown, MS, PMP

Merck & Co., Inc., United States

Senior Director, Medical Writing

Katie  Bates


Katie Bates

Whitsell Innovations, Inc., United States

Medical Writer and Consultant

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