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Mar 22, 2021 9:50 AM - Mar 24, 2021 2:30 PM

(Eastern Standard Time)

Medical Affairs and Scientific Communications Forum

Session 4 Track 2: End-to-End Messaging in Medical Writing

Session Chair(s)

Ruggero  Galici, PhD

Ruggero Galici, PhD

Director, Nonclinical and Clinical Pharmacology Writing

Alexion Pharmaceuticals, AstraZeneca Rare Disease, United States

End-to-end messaging ties what we are doing now to what we want to achieve in the end, which is the approved label in the pharmaceutical industry. This session will describe a roadmap and will highlight the key steps and documents that make up the pathway from early drug development to approval. How do our documents contribute to the messaging pathway as knowledge is gained over time? In today’s environment, the pressure to accelerate the process means we must plan early and pre-populate submission documents before final data release, then work in parallel to complete them. Understanding the End-to-End messaging pathway and how it relates to decision points during drug development is important for successful regulatory submissions and publications

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe the basic end-to-end message pathway
  • Utilize decision point roadmap
  • Recognize where project work lies in the decision point pathway and which documents affect it.


Becky  Nuttall, BSN, RN

End-to-end Messaging and the Decision Point Roadmap

Becky Nuttall, BSN, RN

Pfizer, Inc., United States

Medical Writer, Director

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