• Global regulatory strategy considerations and construction
• Description of local regulatory environments and requirements for drug development in greater Europe, US, China and Japan
• Unique challenges in selected global markets
• Interactions with regulators in different global markets
• Europe, US, China and Japan regulatory strategic considerations
• Overviews of the rapidly changing regulatory environment in selected countries in Asia Pacific, Latin America, Russia and Africa

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

• Regulatory affairs
• Clinical development
• Research and development
• Project management
• Project managers

Level: Intermediate. Participants should have a basic knowledge and understanding of Regulatory processes.

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

• Discuss building global drug regulatory strategies including how to develop one in the context of global project teams
• Compare the unique and diverse challenges of working within different regulatory environments, regulators, and cultures
• Determine the best ways of communicating effectively with drug regulatory authorities
• List key regulatory requirements for drug development and approval in selected global markets

Participants will engage in learning exercises during the course.

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

• Focus
• Flexibility
• Convenience
• Cost Effectiveness

For more information please contact EMEA@DIAglobal.org