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Session 5 Track 2: Lean Authoring and Global CTD Submission
Session Chair(s)
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
Speaker(s)
Speaker
Elizabeth Brown, MS, PMP
Merck & Co., Inc., United States
Executive Director, Medical Writing & Disclosure
Speaker
Katie Bates
Whitsell Innovations, Inc., United States
Medical Writer and Consultant
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