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The Role of Medical Writers in Preparing Responses to Post-Submission Queries From FDA, PMDA, and EMA

Time

Tue, Jun 17 7:15AM
T 29

Title

The Role of Medical Writers in Preparing Responses to Post-Submission Queries From FDA, PMDA, and EMA

Abstract Summary

Compare and contrast the medical writer’s experience in preparing responses to post submission queries from the FDA, PMDA, and EMA. Different approaches and styles across the regulatory agencies will be discussed in this presentation.

Poster Presenter

Kai Yu Jen
Senior Regulatory Writer, Global Regulatory Writing ,
Biogen Idec
United States