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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In...

Session Chair(s)

John  Hicks, MBA, MSc

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)

John  Hicks, MBA, MSc

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

Esther M. Huffman, MA

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

Maryrose  Petrizzo, MS

Industry Perspective

Maryrose Petrizzo, MS

Clinical Quality Assured,LLC, United States

President and Consultant

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