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.

Dur. aprox.
39 minutos