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Session 4, Track B: Pharmacovigilance Inspections in Latin America – Current Scenario, Expectations and Trends
Session Chair(s)
Arthur Bueno, PharmD, MBA
Country Safety Head Back-Up
Sanofi Brazil, Brazil
Josue Bautista, PharmD
GCP/PV Auditor
Novartis, Mexico
In this session, speakers will discuss the current scenario for Pharmacovigilance Inspections in Latin America, considering the main concerns, trends and the expectations from the Regulatory Bodies for the Pharmacovigilance systems for the regulated sector.
Learning Objective : - Recognize the main trends and concerns for Pharmacovigilance Inspections in Latin America
- Understand the Regulatory expectations for the Pharmacovigilance Processes set-up for the regulated sector in Latin America
- Identify opportunities for Pharmacovigilance processes alignments/improvements considering the lessons learned from Pharmacovigilance Inspections in Latin America
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