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Session Chair(s)
Michelle L. Charles, MPH
Director, Regulatory Affairs, Gene Therapy Program, University of Pennsylvania, Perelman School of Medicine, United States
Learning Objective : •Discussion on Regulations for Clinical Monitoring •Practical difficulties/issues faced by sponsor/CRO, during monitoring : Case Studies •How to formulate most efficient monitoring plan •Execution of remote monitoring in flexible manner, despite achieving purpose of monitoring
Speaker(s)
Ashok Ghone, PHD
VP, Global Services, MakroCare, United States
Implementing Risk Based Monitoring Approach to Clinical Trials
Kelley Robinson
TMF/Registry Process Analyst, Pfizer, United States
Essential Document Management - Using Metrics to Drive Compliance and Provide Oversight
Paul Nalepa
Assoc. Manager, Information Governance & Compliance, Global Quality & Compliance, PPD, United States
eTMF – Options for the Sponsor When Working With A CRO