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Defining, Measuring, and Assessing "Fit for Purpose" Quality in a Risk-Based Monitoring Model: Industry and Agency Perspectives

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
136

Room Number:
5B

Level:
Intermediate

Type:
Session

Title:
Defining, Measuring, and Assessing "Fit for Purpose" Quality in a Risk-Based Monitoring Model: Industry and Agency Perspectives

Chair(s):
John Poland, PhD
Senior Director, Regulatory Policy and Compliance, Clinical Development Services
Covance Inc. , United Kingdom

Description:
FDA and EMA guidance encourage a shift from 100% data verification to “fit for purpose” trial quality. Key concepts, metrics that allow trial oversight, and how trial quality can be reported and assessed will be addressed in this context.

Learning Objective(s):
Apply the concept of "fit for purpose" quality to a risk-based clinical trial monitoring model; Develop suitable metrics for the measurement and assessment of "fit for purpose" trial quality.

Presentation(s) & Speaker(s):
EMA Perspective
Anabela Marcal, PharmD
Head of Compliance and Inspections Department
European Medicines Agency, European Union, United Kingdom

FDA Perspective
Jean Mulinde, MD
Acting Senior Advisor, Division of GCP Compliance, OSI, CDER
FDA, United States

Industry Perspective
Mike Sobczyk, MSc
Senior Director, Regulatory Compliance
Gilead Sciences, Inc., United States