(0)

DIAアカウントをお持ちの場合、サインインしてください。

サインイン

ユーザーIDをお忘れですか？ or パスワードをお忘れですか？

Not a Member?

アカウントを作成して参加。

DIA Global Center

2017年9月14日 (木) 午前 8:15 - 2017年9月15日 (金) 午後 4:15

21 Dupont Circle NW, Suite 300, Washington, DC 20036

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

概要

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. 

何を学ぶか

  • 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

参加対象

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

学習目的

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

Digital Learning Catalog

DIA Learning: eLearning Soultions
Download

最新情報や機会を逃さないで

DIAのメールを購読すれば、常に最新の業界情報やイベント情報を得ることができます。