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Innovative Approaches to Predictive Clinical Safety and Signal Detection Utilizing Clinical Pharmacology Concepts
Session Chair(s)
Howard Greenberg, DrMed, MD, MBA, MS
Medical Safety Officer
Janssen Research and Development, LLC, United States
Pharmacovigilance analyzes spontaneous reports to assess potential safety concerns. Newer methods that may predict potential issues, coupled with enhanced observational methods using patient-generated data may complement the traditional approaches.
This session has been developed by the DIA Clinical Pharmacology Community.
Learning Objective : Describe innovative approaches to pharmacovigilance that can augment traditional methods; Distinguish traditional approaches from newer methodologies and their synergistic use; Assess the potential value of using predictive safety methods and newer signal detection methodologies.
Speaker(s)
Utilization of Social Media for Postmarketing Surveillance: Proof of Concept Study with PatientsLikeMe Data for Signal Detection
Amy Purrington, MD
Janssen Pharmaceuticals, Inc., United States
Head, Signal Management Group
Pharmacological Mechanism-Based Drug Safety Prediction: Approach to non-QT Tyrosine Kinase Inhibitor Cardiotoxicity
Darrell R. Abernethy, MD, PhD
FDA, United States
Associate Director for Drug Safety, Office of Clinical Pharmacology, CDER
Holistic Signal Detection: Leveraging Multiple Data Sources to Improve the Accuracy and Timeliness of Signal Detection
Rave Harpaz, PhD
Oracle Health Sciences, United States
Senior Research Scientist
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