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Country-Specific Clinical Data and Reporting Requirements in Support of Marketing Applications To Key Rest-of-World Countries

Time

Tue, Jun 17 7:15AM
T 06

Title

Country-Specific Clinical Data and Reporting Requirements in Support of Marketing Applications To Key Rest-of-World Countries

Abstract Summary

Regulatory guidelines were reviewed for China, Japan, Korea, Taiwan, Mexico, India, and Russia. These countries have established requirements for the inclusion of clinical data reflective of the local population in order to facilitate the review of a marketing application.

Poster Presenter

Marianne K Pedersen
PhD,
Associate Director, Global Regulatory Documentation,
Bristol-Myers Squibb Company
United States