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.?