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Exploring the Evolution of Signal Detection
Session Chair(s)
Stephen Knowles, MD, MRCP
Chief Medical Officer
Halozyme Therapeutics, United States
Since the initial release of GVP Module IX - Signal Management, pharmacovigilance organizations have gained a considerable amount of experience. The EMA has released Module 9 R2, which incorporates the key learnings to date. This session will explore notable changes, advances in signal management, and how organizations are adapting to meet the new guidelines.
Learning Objective : Describe the updates to Module 9 and how they impact one's pharmacovigilance organization.
Speaker(s)
Evolving Signal Detection: Frequency-Based Approaches to Data Mining
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences
Advances in Signal Management: Process, Data, and Methods
William Blackwell
Commonwealth Informatics, United States
Vice President Safety Solutions
Signal Management in Practice
Stephen Knowles, MD, MRCP
Halozyme Therapeutics, United States
Chief Medical Officer
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