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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Innovations in Proactive Quality Management: Best Practices and Variability in Approaches to Proactive Quality Management

Session Chair(s)

Steven B. Whittaker

Steven B. Whittaker

Executive Director, Quality Consortium

The Avoca Group, United States

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.

Learning Objective : Discuss different approaches being used by the industry in proactive quality management; Describe how companies measure and implement quality standards; Identify tools for proactive quality management.

Speaker(s)

Jennifer G. Marsh

Panelist

Jennifer G. Marsh

Eli Lilly and Company, United States

Senior Director, Global Medical Quality

Coleen  Glessner, MBA

Panelist

Coleen Glessner, MBA

Alexion Pharmaceuticals, United States

Senior Vice President, Chief Quality Officer

Ann  Meeker-O'Connell, MS

Panelist

Ann Meeker-O'Connell, MS

FDA, United States

Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC

Fergus  Sweeney, PhD

Panelist

Fergus Sweeney, PhD

European Medicines Agency, Netherlands

Head of Clinical Studies and Manufacturing Task Force

Cassandra  Kennedy

Panelist

Cassandra Kennedy

Quintiles Inc., United States

Senior Vice President, Global Quality Assurance

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