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Tuesday, June 20 • 4:00pm - 5:00pm
#286: Audits and Agency Inspections of Risk-Based Monitored Studies: The Results Are In...

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

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 Objectives

Discuss the implementation of the risk-based monitoring approach as judged by auditors and inspectors.

Chair

John Hicks, MBA, MSc

Speaker

Evaluation of Risk-Based Monitoring From the Perspective of the Sponsor’s GCP Auditor
John Hicks, MBA, MSc

Results from Five Years of Risk-Based Monitoring Studies: Experience with Health Authorities and Internal Auditors
Esther M. Huffman, MA

Industry Perspective
Maryrose Petrizzo, MS



Moderators
avatar for John Hicks

John Hicks

Global Quality Auditing Manager, Eli Lilly and Company
Over 20 years experience in management and auditing clinical study activity ensuring and evaluating compliance to Good Clinical Practices, and applicable regulatory regulations. Provided project and clinical trial management expertise for global research in multiple phases and th... Read More →

Speakers
avatar for John Hicks

John Hicks

Global Quality Auditing Manager, Eli Lilly and Company
Over 20 years experience in management and auditing clinical study activity ensuring and evaluating compliance to Good Clinical Practices, and applicable regulatory regulations. Provided project and clinical trial management expertise for global research in multiple phases and th... Read More →
EH

Esther Huffman

Associate Director, Monitoring Excellence, Bristol-Myers Squibb
Esther is an Associate Director in the Monitoring Excellence Group at Bristol-Myers Squibb, where she has spent the past several years developing and operationalizing the Risk-Based Monitoring methodology. In her current role, Esther facilitates the changes in technology, process... Read More →
avatar for Maryrose Petrizzo

Maryrose Petrizzo

President and Principal Consultant, Clinical Quality Assured, LLC
Maryrose has over 20years of GCP experience in Clinical QA and Quality Systems for the pharmaceutical, biologics and medical device industries including: site and process auditing, inspection readiness, due diligence, acquisition integrations, and clinical vendor management. Alwa... Read More →


Tuesday June 20, 2017 4:00pm - 5:00pm
S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616