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Session Chair(s)
Elizabeth E. Garrard, PHARMD
Executive Vice President, Global Safety Operations
Clinipace Worldwide, United States
Learning Objective : Describe the regulations governing quality assurance for signal detection programs; Recognize how to develop a quality assurance program that assesses compliance with signal detection activities; Explain how to generate metrics for the effectiveness and efficiency of a signal detection program.
Speaker(s)
Quality Assurance and Quality Management Measures With Respect to Signal Detection and Signal Management: A Priority in the EU Pharmaceutical Legislation and Guidance
Kerstin Geldmeyer-Hilt, PHD
Dr. Ebeling & Assoc. GmbH, Germany
Quality Manager
EU Perspective
Morell B. David, MSC
The Lewis David Consultancy Ltd, United Kingdom
Director & Principal Consultant
Industry Point of View
George N. Pajovich, RPH
Pfizer Inc, United States
VP, Head of Safety Quality and Risk Management
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