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Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In...
Session Chair(s)
John Hicks, MBA, MSC
Global Quality Auditing Manager
Eli Lilly and Company, United States
Sponsors, investigator sites, regulators and CRO organizations are invited to share the results of audits and inspections in which risk-based monitoring studies have been assessed.
Learning Objective : Discuss the implementation of the risk-based monitoring approach as judged by auditors and inspectors.
Speaker(s)
Evaluation of Risk-Based Monitoring From the Perspective of the Sponsor’s GCP Auditor
John Hicks, MBA, MSC
Eli Lilly and Company, United States
Global Quality Auditing Manager
Results from Five Years of Risk-Based Monitoring Studies: Experience with Health Authorities and Internal Auditors
Esther M. Huffman, MA
Bristol-Myers Squibb, United States
Associate Director, Monitoring Excellence
Industry Perspective
Maryrose Petrizzo, MS
Clinical Quality Assured,LLC, United States
President and Consultant