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Session 1, Track C: Pharmacovigilance Regulatory Requirements: Challenges and News for the Future
Session Chair(s)
Gislaine Villarta Capeleti Dib, PHARMD
Operational Manager, PGA Farma, Brazil
Josue Bautista, PHARMD
GCP/PV Auditor, Novartis, Mexico
Rosana M. Mastellaro, PHARMD, RPH
Director, Technical Regulatory Affairs and Innovation, Sindusfarma, Brazil
This session will provide insights and updates from various regulatory Health Authorities (HA) in Latin America on their current challenges, priorities, plans, projects and updates relating to pharmacovigilance (PV). Gain a broader understanding of the current regulatory PV systems in Latin America with perspectives presented.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe current drug safety and PV rules and processes, regulatory trends, and expectations for compliance
- Create strategies convergent with the priorities established for regulatory PV systems
- Identify challenges and opportunities for future PV projects
- Analyze opportunities to better interact and communicate with regulatory PV systems
Speaker(s)
Veronica Marcela Vergara Galvan, MSC
Head, Pharmacovigilance Subdepartment, Instituto de Salud Pública de Chile, Chile
Advances and Challenges in Pharmacovigilance
Head of the National Pharmacovigilance Center, Ministry of Health of Costa Rica, Costa Rica
Challenges and Agenda for Pharmacovigilance in Brazil
Pharmacovigilance Manager, ANVISA, Brazil
Challenges and Agenda for Pharmacovigilance in Mexico
Executive Director of Pharmacopoeia and Pharmacovigilance, COFEPRIS, Mexico
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