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35th Brazilian Congress of Pharmaceutical Medicine

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FDA GCP Inspections in Latin America. Findings and where we must improve

Programa
35th Brazilian Congress of Pharmaceutical Medicine

Tema
FDA GCP Inspections in Latin America. Findings and where we must improve

Descrição
35th Brazilian Congress of Pharmaceutical Medicine Chair: Ricardo Eccard da Silva. Avisa. Brazil Co-Chair: José Eduardo Neves. AstraZeneca. Brazil Tema: FDA GCP Inspections in Latin America.
Findings and where we must improve.
Palestrante: David Lepay – FDA. USA Assuntos abordados: – What This Talk Will Cover – Jurisdiction and Inspecting – Corollary – Dispelling Some Additional Myths – FDA´s GCP Expectations – Multinational Studies – Local Laws/Regulations – FDA GCP Inspections – Anatomy of an FDA Inspection – Official Action (OAI) “Sanctions” Available to FDA under IND – Website for List of Disqualified CIs – FDA CI International Inspection Experience – FDA GCP Inspections in Brazil – Where Investigators Go Wrong: THE BIG FIVE – Some Citations from International OAI Inspection Letters – Closing Perspectives.

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39 minutos

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