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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)
Implementing Risk Based Monitoring Approach to Clinical Trials
Ashok Ghone, PhD
MakroCare, United States
VP, Global Services
Essential Document Management - Using Metrics to Drive Compliance and Provide Oversight
Kelley Robinson
Pfizer, United States
TMF/Registry Process Analyst
eTMF – Options for the Sponsor When Working With A CRO
Paul Nalepa
PPD, United States
Assoc. Manager, Information Governance & Compliance, Global Quality & Compliance