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Quality Assurance for Signal Detection Programs
Session Chair(s)
Elizabeth E. Garrard, PharmD
Executive Vice President, Global Safety Operations
Clinipace Worldwide, United States
New EU legislation requires quality assurance of critical safety processes, including signal detection. This forum will offer the chance to discuss how best to measure compliance, effectiveness, and efficiency of a signal detection program.
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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