Regulatory Labeling Experiences with the PSUR Worksharing Process

Time

Tue, Jun 26 11:00AM
T 27

Title

Regulatory Labeling Experiences with the PSUR Worksharing Process

Abstract Summary

The goal of the PSUR Worksharing project is to have a single PSUR in all member states where the product is authorized and includes a Core Safety Profile (CSP). This poster shows a company experience with the procedure and the impact the CSP may have on the company’s core labeling.

Poster Presenter

Eileen S. Kahn
MEd, MS,
Principal Labeling Associate,
Sanofi
United States

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