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Session 5, Track B: New Era for Signal Detection
Session Chair(s)
Gislaine Villarta Capeleti Dib, PHARMD
Operational Manager, PGA Farma, Brazil
Yoon Jeon (Jamey) Kim, MSC, RPH
Director, Cluster Pharmacovigilance Lead, Merck & Co., Inc., Rahway, NJ, USA, Panama
In this session, we will Navigate the new era of pharmacovigilance, exploring innovations in signal detection across various sources and products. We will discuss the impact of innovative signal detection approaches on patient safety.
Learning Objective : - Gain insights on regulatory considerations, methods and types of initiatives in the LATAM Region
- Examine the integration of multi-modal data sources and products for comprehensive signal detection and validation
- Recognize common challenges/traps and ways out in the new era of pharmacovigilance
- Evaluate case studies and success stories showcasing the impact of innovative signal detection approaches on patient safety
Speaker(s)
Mariângela Luchezi, RPH
Sr Associate - Clinical Surveillance, Eli Lilly and Company, Brazil
Handling Multiple Data Sources and Large Databases in Signal Evaluation
Stefania de Azevedo Fraletti, MBA, MPHARM
Sr. Quality Assurance, Customer and Scientific Information Services Manager, Novo Nordisk, Brazil
Signal Detection in High Social Media Exposure Scenario
Marcelo Eiji Koike, PHARMD, MBA
Pharmacovigilance Specialist, Instituto Butantan, Brazil
Case Study of Automation in Signal Detection Implemented by a Brazilian Public Laboratory
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