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Boston Convention and Exhibition Center

2018年6月24日 (日) 午前 8:30 - 2018年6月28日 (木) 午後 12:00

415 Summer Street, , Boston, MA 02210 , USA

DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Assessing Your Clinical Quality Management System: An In-Depth Look at TransCelerate’s Assessment Tool

Session Chair(s)

Janis A Little, MS

Janis A Little, MS

Vice President, Global R&D Quality

Allergan Inc, United States

This co-presented workshop will provide an overview of the Transcelerate Clinical Quality Management System Framework tools that are available and also will include a demonstration of the TransCelerate Assessing a Clinical QMS Tool and how an attendee may approach an initial assessment of their organization’s Clinical QMS as to generate a baseline assessment.

Learning Objective : Describe the proposed QMS framework and how it may be used to drive excellence in Clinical Development; Identify considerations and processes that may be used in assessing an organization’s clinical quality management system in alignment with the QMS Concept Paper; Describe key benefits of assessing a clinical QMS within the context of your organization’s quality goals/objectives.

Speaker(s)

Janis A Little, MS

Overview of Transcelerate Clinical Quality Management System Framework Tools

Janis A Little, MS

Allergan Inc, United States

Vice President, Global R&D Quality

Michael  Husovich

Assessing the Clinical Quality Management System: An In Depth Look at TransCelerate’s Assessment Tool

Michael Husovich

Amgen Inc., United States

Director, Global R&D Quality

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