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Innovations in Proactive Quality Management: Best Practices and Variability in Approaches to Proactive Quality Management
Program Code:
378
Date:
Wednesday, June 26, 2013
Time:
4:00 PM to 5:30 PM
EST
CHAIR
:
Steven B. Whittaker, (SCHNON), The Avoca Group, United States
SPEAKER
(S):
Jennifer G. Marsh, (SPKNON), Senior Director, Global Medical Quality, Eli Lilly and Company, United States
Coleen M. Glessner, (SPKNON), Vice President, Clinical Trial Processes and Quality, Pfizer Inc, United States
Fergus Sweeney,
PhD (SPKAGY), Head of Sector, Compliance and Inspection,
European Medicines Agency, European Union, United Kingdom
PhD in pharmacology 1986 Joined EMEA in 1999. Coordination of GCP and Pharmacovigilance inspection. Chairman of the GCP Inspectors Working Group and Ad Hoc Pharmacovigilance Inspectors Working Group. Business analyst for the EudraCT database.
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Cassandra Kennedy,
(SCHNON), Senior Vice President, Global Quality Assurance,
Quintiles Inc., United States
Cassandra Kennedy serves as the Sr. Vice-President for Global QA at Quintiles and is a member of the Enterprise Compliance Office. In this position, Ms. Kennedy is responsible for directing Quality Assurance for Clinical Research, Clinical Laboratory, Phase I Units, and Systems Compliance.
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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.
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Description
This forum will explore industry best practices and the variability in industry approaches to quality management. Data from the 2012 Quality Consortium Assessment research will be shared. A panel of industry experts and representatives from the FDA and EMA will provide their perspectives.