American Conference Institute's FDA Enforcement Summit

Exploring the International Reach of FDA Enforcement

• understanding the scope and source of FDA authority worldwide
• The international inspection process: comparing and contrasting to U.S. inspections
• Appreciating the new global cooperation and enforcement measures
• The significance of FDA opening offices in China and emerging markets
• Examining international harmonization efforts:
  • joint FDA and EMEA GCP, GMP policies
  • understanding how FDA inspections operate in tandem in BRIC countries and other emerging markets (Brazil, Russia, India, China)
• Knowing and applying the proper jurisdictional requirements for manufacturing, securing informed consent, and setting up the CTA
  • how does FDA assert its authority in these situations of conflicting jurisdictional requirements?
  • how does the agency handle enforcement for manufacturing recalls and warning letters for products distributed in the U.S.?