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Tuesday, June 28 • 2:00pm - 3:15pm
#244: Transforming Clinical Development Through Enterprise Quality Management

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Quality oversight throughout the clinical development life cycle is complex, crosses many functions, and can pose changes in seamlessly communicating and managing quality risks identified along the way. This session will discuss the role of executive leadership in driving and ensuring transparent communication about quality throughout an organization. Additionally, presenters will describe how their organizations have developed and implemented a enterprise quality management approach tailored to their particular context.

Learning Objectives

Identify the benefits of implementing a holistic, clinical-focused quality management system; Discuss how enterprise quality management can be tailored to an organization’s operating context; Recognize how executive leadership can drive a quality-focused culture and timely execution.

Chair

Ann Meeker-O'Connell, MS

Speaker

Executive Leadership Position on Quality
John Hubbard, PhD

Establishing a Quality Management System During Accelerated Growth of a Lean Operation
Coleen Glessner, MBA

Research and Development QA Integrated Quality Strategy: An Approach to Ensuring Quality and Managing Quality Risks Across the Drug Life Cycle
Kevin Grebner



Speakers
avatar for Coleen Glessner

Coleen Glessner

Vice President, R&D Quality and Compliance, Alexion
As Vice President, Head of Research and Development Quality and Compliance at Alexion, Coleen leads the establishment of a quality management system for R&D to assure the highest standards of Quality in ultra-rare diseases. Most recently, she has been focused on implementing sustainable processes and controls for Alexion’s accelerated growth while developing a culture of quality. She has a BS from the University of Pittsburgh and an MBA from... Read More →
avatar for Kevin Grebner

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie Inc.
Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has held various positions in a variety of organizations including Clinical Development, Clinical Outsourcing, and Drug Discovery. Kevin has a B.S. in Chemistry from... Read More →
avatar for John Hubbard

John Hubbard

President and Chief Executive Officer, BioClinica
Dr. Hubbard has held positions of increasing responsibility in the Pharmaceutical, SMO and CRO industries. In his current position as Global President of the Clinical Research Division for ICON plc, he has oversight of more than 4,400 employees conducting 360 projects in 55 offices and 32 countries


Tuesday June 28, 2016 2:00pm - 3:15pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA