Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

DIA Global Center

Aug 03, 2015 8:30 AM - Aug 04, 2015 4:15 PM

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

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

Overview

Most regulatory professionals focus their careers on the regulations of a single country or region such as the US or EU. In order for a global regulatory leader to be truly effective, it is critical to understand the key regulatory issues in all major markets and to apply this knowledge to a global regulatory strategy. Communication between health authorities is increasing, making it vitally important that regulatory leaders develop their strategies with a global view. In addition, current trends in the pharmaceutical industry indicate that more and more companies are expanding their global presence to benefit from the explosive growth being projected in the emerging markets. It is essential, therefore, that a global regulatory leader possess the knowledge and skills necessary to enable successful product registrations in multiple markets around the world.
   
This course will allow participants to understand key requirements for the development and execution of a global regulatory strategy by identifying the strategic and tactical aspects of pharmaceutical development in the US, EU and emerging markets.  Course participants will have the opportunity to apply learning objectives in a hands-on workshop.

Course Level: Intermediate


The DIA training course offerings which are available to pharmaceutical professionals are truly excellent. There is a nice array of topics to choose from and no matter what space you reside in (regulatory, clinical, data management, etc.), you should be able to find something that suits your needs.

What you will learn

  • Survey of the Global Regulatory Landscape
  • Unique Challenges in Emerging Markets
  • Assembling and Working with Global Development Teams
  • Constructing and Implementing Global Regulatory Strategies

Who should attend?

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

  • Regulatory Affairs with basic knowledge of investigational and marketing applications
  • Business Development
  • Commercial or Marketing
  • Clinical Development
  • Regulatory CM&C
  • Academic Research

Learning objectives

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

  • Explain the importance of the regulatory strategy in pharmaceutical  development and commercialization
  • Apply key requirements for development in a global market to product strategy
  • Plan for the implementation of the Global Regulatory Strategy across multiple regions
  • Identify development areas requiring special considerations across various regions

Digital Learning Catalog

DIA Learning: eLearning Soultions
Download

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.