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Overview

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 developmnet 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:

  • Regulatory affairs
  • Clinical development
  • Research and development
  • Medical
  • Commercialization and market access
  • Project managers

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