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Medical Affairs and Scientific Communications Forum
Session 5 Track 2: Lean Authoring and Global CTD Submission
- Director, Regulatory Services Management
- Certara Synchrogenix, 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
- Director, Oncology Medical Writing Lead
- Merck & Co., Inc., United States
- Medical Writer and Consultant
- Whitsell Innovations, Inc., United States
Preconference Short Courses
Medical Communications Primer: The Fundamentals of Medical Communications
Short Course #1: Medical Communications: Compliance in 2022
Short Course #2: Advertising and Promotional Content Review: The Role of Medical Information
Short Course #3: Statistics for Non-Statisticians
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