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

Session 3: Unique Challenges Outside the United States and the European Union

• Culture and communication
• Requirements in local investment
• Investing in infrastructure
• Potential regulatory hurdles
• Expectations around investigational drug availability after clinical studies

• Optimizing meeting opportunities
• Anticipating and managing queries
• Culture and communication
• Crisis management and issue resolution