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GCP Risk-based Monitoring
Session Chair(s)
Kathy Goin, MS
Vice President, Clinical Operations
Trevena Inc., United States
Mission Possible: Creating a Trial Quality Profile
Learning Objective : Discuss attitudes and expectations of research personnel with regard to monitoring within the context of the new FDA "Guidance for Industry Oversight of Clinical Investigations"; Identify and analyze trial metrics to improve quality and performance; Discuss how to develop a trial quality profile; Define how to obtain support for and implement risk-based monitoring strategies.
Speaker(s)
Mission Possible: Creating a Trial Quality Profile
Penelope K. Manasco, MD, MS
MANA RBM , United States
Chief Executive Officer
Like a Fine Wine, Risk-based Monitoring Approaches Take Time
Kathy Goin, MS
Trevena Inc., United States
Vice President, Clinical Operations
New Monitoring Approaches: Evolution or Revolution?
Sherri Ann Hubby
Myovant Sciences , United States
Senior Director, GCP Quality Assurance
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