Clinical Trial Requirements U.S. vs. EU Similarities and Differences

Clinical Trial Requirements Similarities and Differences US vs. EU Anita Fenty Covance, Inc

LEGAL FRAMEWORK ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CLINICAL TRIAL APPLICATION US ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CLINICAL TRIAL APPLICATION EU ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

INSTITUTIONAL REVIEW BOARD/ ETHICS COMMITTEE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CONDUCT OF CLINICAL TRIAL US ,[object Object],[object Object],[object Object],[object Object]

CONDUCT OF CLINICAL TRIAL EU ,[object Object],[object Object],[object Object]

ESSENTIAL DOCUMENT RECORD RETENTION US ,[object Object],[object Object]

ESSENTIAL DOCUMENT RECORD RETENTION EU ,[object Object],[object Object],[object Object]

ESSENTIAL DOCUMENT RECORD RETENTION EU ,[object Object],[object Object],[object Object],[object Object]

INVESTIGATIONAL MEDICINAL PRODUCT (IMP) REQUIREMENTS US ,[object Object],[object Object]

INVESTIGATIONAL MEDICINAL PRODUCT (IMP) REQUIREMENTS EU ,[object Object],[object Object],[object Object]

INVESTIGATIONAL MEDICINAL PRODUCT (IMP) REQUIREMENTS EU ,[object Object],[object Object]

ADVERSE EVENT REPORTING US ,[object Object],[object Object],[object Object]

ADVERSE EVENT REPORTING US ,[object Object],[object Object],[object Object],[object Object],[object Object]

ADVERSE EVENT REPORTING US ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

ADVERSE EVENT REPORTING EU ,[object Object],[object Object],[object Object]

ADVERSE EVENT REPORTING EU ,[object Object],[object Object],[object Object],[object Object]

ADVERSE EVENT REPORTING EU ,[object Object],[object Object]

ADVERSE EVENT REPORTING EU ,[object Object],[object Object],[object Object],[object Object],[object Object]

REGULATORY COMPLIANCE US ,[object Object],[object Object]

REGULATORY COMPLIANCE US ,[object Object],[object Object],[object Object]

REGULATORY COMPLIANCE US ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

REGULATORY COMPLIANCE EU ,[object Object],[object Object],[object Object],[object Object],[object Object]

DISCUSSION/ QUESTIONS/COMMENTS ,[object Object],[object Object],[object Object]

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