Latin America Annual Meeting

Take advantage of opportunities for networking and knowledge sharing with key stakeholders influencing the advancement and implementation of initiatives in Latin America.

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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