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Wednesday, June 29 • 10:30am - 11:45am
#319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development

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Limited Capacity seats available

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

Knowledge is a valuable asset that organizations acquire through experience and possess within their employees. Implementing a structured approach to managing knowledge can effectively help achieve desired business outcomes of quality improvements and employee engagement. This session will provide an overview of key principles of knowledge management (KM), discuss elements of a KM framework that can support application within clinical development, and offer ideas on how KM practices can be applied to specific business processes.

Learning Objectives

Recognize key principles of knowledge management and suggested approaches to implementation strategy; Identify a knowledge management framework that can be tailored and applied within a clinical development organization; Discuss how knowledge management may be applied to a specific business process or functions.

Chair

Kathy Salzano

Speaker

Overview of TransCelerate Conceptual Knowledge Management Framework
Christa A. Maurer

Unlocking the Mystery of Knowledge Management: Applying Concepts to a Trial Master File
David William Fryrear, MSc

Application of Knowledge Management in Regulatory Intelligence
Carolyn Louise Hynes, PhD



Chair
avatar for Kathy Salzano

Kathy Salzano

Director, Quality and Continuous Improvement, Merck & Co., Inc.
Kathy Salzano is a Director of the Quality and Continuous Improvement organization at Merck & Co., Inc. Kathy has over 25 years of experience at Merck in various leadership roles supporting the execution and oversight of GCP quality and compliance programs within Clinical Development. Since 2014, she has been actively involved in the TransCelerate Biopharma Inc. initiatives tied to Clinical Quality Management Systems (QMS) and Knowledge... Read More →

Speakers
avatar for David Fryrear

David Fryrear

Senior Director, R&D Quality Assurance, Abbvie
David Fryrear is a senior director in R&D Quality Assurance at AbbVie. David leads the global QA team responsible for Clinical, PV, and RA quality strategy, continuous improvement projects, and audits and quality knowledge management activities. Prior to joining AbbVie in January of 2013, he had been at Eli Lilly for 23 years, the last 12 in leadership positions in quality assurance. David has an M.S. in Pharmaceutical Science from Butler... Read More →
avatar for Carolyn Hynes

Carolyn Hynes

Senior Director, Global Regulatory Intelligence, GlaxoSmithKline
Carolyn Hynes is a Senior Director in the Global Regulatory Affairs Department at GlaxoSmithKline and is based in the UK. She leads the Global Regulatory Intelligence team. Prior to joining GSK in 2011, she spent 10 years working at Janssen Research & Development where she was a Director in the Global Regulatory Policy and Intelligence group.
avatar for Christa Maurer

Christa Maurer

Sr. Compliance Specialist, Bristol-Myers Squibb Company
For the past 5 years, Christa has managed a team of Quality Managers responsible for operational risk management and inspection readiness in Asia and the Americas. She previously worked abroad in China and India in her quality role. Her prior experience includes Outsourcing & Contract Management, Line Management, and various roles in clinical trial operations. She has been a member of the TransCelerate QMS workstream since September 2014.


Wednesday June 29, 2016 10:30am - 11:45am
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA