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Part 1 - Current Trends in Pharmaceutical/Medical Device Development Impacting Monitoring
Session Chair(s)
Paul Krause
Celgene Corporation, United States
- Current clinical development landscape and challenges requiring change
- Define the purpose of monitoring
- Impact of Risk-Based Monitoring (RBM) Approaches
- FDA Guidance on RBM
- EMEA Reflection Paper on Risk-Based Quality Management
- TransCelerate Position Paper on RBM
- Compare RBM approaches in FDA Guidance to TransCelerate
- Selection and training of monitors
- Effective resourcing of monitors
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