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Session 8, Track B: Technological Advancements and Data Utilization Opportunities in Pharmacovigilance
Session Chair(s)
Arthur Bueno, PharmD, MBA
Country Safety Head Back-Up
Sanofi Brazil, Brazil
Yoon Jeon (Jamey) Kim, MSc, RPh
Director, Cluster Pharmacovigilance Lead
Merck & Co., Inc., Rahway, NJ, USA, Panama
In this session, speakers will discuss the current scenario for technological advancements and how it can support pharmacovigilance operational activities. Within this scenario, data utilization opportunities and limitations will also be discussed and explored from a pharmacovigilance point of view, considering opportunities for business and regulatory submission.
Learning Objective : - Identify how most recent technological advancements can support pharmacovigilance operational activities
- Understand the current real-world data/real-world evidence utilization scenario in Latin America for pharmacovigilance, including opportunities and limitations
- Recognize opportunities and limitations for pharmacovigilance data utilization for business and regulatory submissions
Speaker(s)
Current Scenario for Technological Advancements / AI in PV Activities
Simone de Oliveira Reis Rodero, RAC
ANVISA, Brazil
General Manager, Regulation and Health Surveillance
Real-world Data for Pharmacovigilance in the Context of Regulatory Decision Making
Juhaeri Juhaeri, PhD
Sanofi, United States
Vice President and Global Head, Epidemiology and Benefit-Risk Evaluation
Real World Data Usage in Safety - Cases from Latin America
Guilherme Julian, MS
Pfizer, Brazil
RWD Partnerships Senior Director