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Part 2 - The Details of Site Monitoring
Session Chair(s)
Paul Krause
Celgene Corporation, United States
- Define ICH and FDA requirements for site monitoring
- Regulatory requirements for transferring contractual obligations
- Identify Sponsor responsibilities for oversight
- Introduce “Quality Oversight” programs
- Approaches to monitoring – Centralized and On-Site
- Metrics Champion Consortium – RBM Survey
- Audit/inspection observations and findings regarding site monitoring
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