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Session 4 Track 2: End-to-End Messaging in Medical Writing
Session Chair(s)
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.
Speaker(s)
End-to-end Messaging and the Decision Point Roadmap
Becky Nuttall, BSN, RN
Pfizer, Inc., United States
Medical Writer, Director