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Medical Affairs and Scientific Communications Forum

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Session 5 Track 2: Lean Authoring and Global CTD Submission

Session Chair(s)

David Meats

David Meats

  • 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

Speaker(s)

Elizabeth Brown, MS, PMP

Speaker

Elizabeth Brown, MS, PMP

  • Director, Oncology Medical Writing Lead
  • Merck & Co., Inc., United States
Katie Bates

Speaker

Katie Bates

  • Medical Writer and Consultant
  • Whitsell Innovations, Inc., United States

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Short Course #1: Medical Communications: Compliance in 2022

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Short Course #3: Statistics for Non-Statisticians

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