Oversight of Clinical Monitoring: Trends and Strategies

Part 1:
Current Trends in Pharmaceutical/Medical Device Development Impacting Monitoring
•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
•Advances in technology impacting monitoring
•Selection and training of monitors
•Effective resourcing of monitors

Questions/Answers