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Online

2017 年 05 月 09 日 12:00 下午 - 2017 年 05 月 11 日 2:00 下午

Oversight of Clinical Monitoring: Trends and Strategies

Part 1: Current Trends in Pharmaceutical/Medical Device Development Impacting Monitoring

Session Chair(s)

Lynn  King, MHA

Lynn King, MHA

Consultant

United States

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

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