Approaches to Quality Risk Management: Understanding What Matters
Track
:
Track 02: Project/Portfolio Management and Strategic Planning
Program Code:
244
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
253A
CHAIR
:
Martin Landray, PhD,FRCP (SCHSUP), Reader in Epidemiology, Clinical Trial Service Unit, University of Oxford, United Kingdom
Dr Martin Landray has substantial experience of conducting large-scale, international clinical trials in cardiovascular and renal disease. He continues to develop and promote methods to facilitate the conduct of large-scale trials to generate reliable results that will improve healthcare.
SPEAKER
(S):
Martin Landray, PhD,FRCP (SCHSUP), Reader in Epidemiology, Clinical Trial Service Unit, University of Oxford, United Kingdom
Dr Martin Landray has substantial experience of conducting large-scale, international clinical trials in cardiovascular and renal disease. He continues to develop and promote methods to facilitate the conduct of large-scale trials to generate reliable results that will improve healthcare.
Behm C. Mark, Senior Director, Compliance Advice and Assurance, AstraZeneca LP, United States
Ann Meeker-O'Connell, MS (SPKAGY), Senior Director, QA Clinical Strategy Team Lead, Janssen Pharmaceutica Inc., United States
Ms. Meeker-O’Connell joined CDER’s Office of Scientific Investigations in March 2010. Prior to FDA, Ann spent 10 years in clinical compliance roles in industry and academia. Ann is actively involved in initiatives to develop risk-based approaches to clinical trial design, conduct, and oversight.
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.