American Conference Institute's FDA Enforcement Summit

May 25, 2010
Philadelphia, PA

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.?
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