Simultaneous Marketing Authorization Applications: Pharma Urban Legend or Reality?

Time

Tue, Jun 16 9:00AM
T 41

Title

Simultaneous Marketing Authorization Applications: Pharma Urban Legend or Reality?

Abstract Summary

Following the globally accepted CTD which specifies a standardized format for organization and summarization of all of the quality, safety, and efficacy data required for marketing applications eliminates the need to reformat information necessary for submission to health authorities.

Poster Presenter

Stacie O'Sullivan
Associate Director, Global Regulatory Affairs ,
Eisai Inc.
United States