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Session 3, Track B: Unlocking Deeper Safety Insights with Real-World Evidence in Pharmacovigilance
Session Chair(s)
Raphael Elmadjian Pareschi, PHARMD, MBA
Patient Safety Lead/ Head of Pharmacovigilance Brazil, Roche, Brazil
Rosana M. Mastellaro, PHARMD, RPH
Director, Technical Regulatory Affairs and Innovation, Sindusfarma, Brazil
In this session, we will explore the pivotal role that real-world data (RWD) and real-world evidence (RWE) play in enhancing pharmacovigilance (PV) practices. Integrating RWD and RWE into pharmacovigilance activities offers innovative approaches to monitoring drug safety and effectiveness, providing comprehensive insights into drug performance in diverse patient populations and real-world settings.
Learning Objective : - Describe the pivotal role of Real-World Data (RWD) and Real-World Evidence (RWE) in enhancing modern pharmacovigilance practices
- Identify innovative approaches for integrating RWD/RWE into pharmacovigilance activities to monitor drug safety and effectiveness
- Explain how the use of RWD/RWE generates comprehensive insights into drug performance within diverse patient populations and real-world settings
Speaker(s)
Challenges in Generating Real-World Evidence (RWE)
Specialist at Pharmacovigilance Officer (GFARM), ANVISA, Brazil
Real World Data Usage in Safety in Latin America – The Importance of Open Data
RWD Partnerships Senior Director, Pfizer, Brazil
Unlocking Deeper Safety Insights with Real-World Evidence in Pharmacovigilance
Head of the Quality and Patient Safety Department, Hospital Alemán, Argentina
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