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Session 7, Track B: Good Pharmacovigilance Practices - Inspections and Compliance within Pharmacovigilance in Latin America
Session Chair(s)
Arthur Bueno, PHARMD, MBA
Affiliate Pharmacovigilance Lead - Brazil, Brazil
Maria Victoria Abdala, MHS, RPH, RAC
Director, Pharmacovigilance (PV) Cluster Lead - LA South, MSD, Argentina
This session will focus on the critical aspects of Good Pharmacovigilance Practice (GVP) inspections and compliance, with an emphasis on real-world case examples featuring regulatory experts. Understanding the requirements and best practices for GVP compliance is essential for Pharmacovigilance (PV) professionals to ensure the safety and efficacy of pharmaceuticals while maintaining regulatory adherence and compliance.
Learning Objective : - Describe the landscape of pharmacovigilance inspections in LATAM from the perspectives of regulatory authorities
- Interpret the regulatory framework for pharmacovigilance inspections in LATAM by reviewing key regulations and guidelines governing inspections
- Identify opportunities best practices from regulatory authorities to enhance practices and processes
Speaker(s)
Pharmacovigilance Good Practices - Pharmacovigilance Inspections and Compliance in Latin America
Specialist Health Surveillance - Pharmacovigilance, ANVISA, Brazil
Speaker
Head of the Pharmacovigilance Department of the National Directorate of Pharmacy, Ministry of Health of the Republic of Panama, Panama
Good Pharmacovigilance Practices - Inspections and Compliance within Pharmacovigilance in Latin America
Head of the National Pharmacovigilance Center, Ministry of Health of Costa Rica, Costa Rica
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