Overview

Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets

This intermediate course will provide participants practical real-world, actionable information on the nature and development of global regulatory strategies for drug development, with a focus on markets located outside the United States and Europe. Descriptions of the local regulatory environments and requirements for drug development will be enhanced by case examples and by practical experiences in Asia-Pacific, Latin America, Africa, and other emerging markets.

What you will learn

Global regulatory strategy considerations and construction
Unique challenges outside the United States and the European Union
Regulatory environments and communications with regulators in diverse world markets
Overview of Japan, China, Asia-Pacific markets, Latin America, and other emerging markets

Who should attend?

Pharmaceutical Professionals with an interest in global regulatory requirements in the areas of:

Learning objectives

At the conclusion of this course, participants should be able to:

Discuss building global drug regulatory strategy including how to develop one in the context of global project teams
Compare the unique and diverse challenges of working with different regulatory environments, regulators, and cultures
Determine optimal ways of communicating effectively with drug regulatory authorities located outside the United States and Europe
List the fundamental regulatory requirements for drug development and approval in Japan, China, other significant Asia Pacific markets, Latin America, and other emerging markets

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