Approaches to Quality Risk Management: Understanding What Matters

Track:
Project/Portfolio Management and Strategic Planning

Day & Time:
June 25, 1:45PM - 3:15PM

Session Number:
244

Room Number:
253A

Level:
Intermediate

Type:
Forum

Title:
Approaches to Quality Risk Management: Understanding What Matters

Chair(s):
Martin Landray, PhD,FRCP
Reader in Epidemiology, Clinical Trial Service Unit
University of Oxford, United Kingdom

Description:
This forum will review the Clinical Trials Transformation Initiative’s (CTTI) potential methods to apply principles of Quality by Design and quality risk management to the scientific and operational design of clinical trials.

Learning Objective(s):
Discuss the workshops on quality risk management; Describe general principles for building quality into the design of trials; Identify benefits and obstacles to the adoption of this approach based on feedback from CTTI workshop participants.

Presentation(s) & Speaker(s):
What Are the Key Drivers for Quality?
Martin Landray, PhD,FRCP
Reader in Epidemiology, Clinical Trial Service Unit
University of Oxford, United Kingdom

Quality Risk Assessment and Quality by Design: Principles Not Jargon
Briggs W. Morrison, MD
Head, Global Medicines Department
AstraZeneca, United States

Regulatory Requirement for Ensuring Quality: A US Perspective
Ann Meeker-O'Connell, MS
Director, Division of GCP Compliance (Acting), OSI, Office of Compliance, CDER
FDA, United States