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Session 4: Key Regulatory Trends for Safety in Latin America and Closing Remarks
Session Chair(s)
Raphael Elmadjian Pareschi, PharmD, MBA
Patient Safety Lead/ Head of Pharmacovigilance Brazil
Roche, Brazil
Michelle Rocha de Souza, MBA
Pharmacovigilance Coordinator
Abbvie, Brazil
Rosana M. Mastellaro, PharmD, RPh
Director, Technical Regulatory Affairs and Innovation
Sindusfarma, Brazil
This session will review key aspects of country-level pharmacovigilance systems and their trends. Explore the perspectives from various Health Authorities and the pharmaceutical industry which includes convergence efforts to discuss future challenges of pharmacovigilance.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize how different adverse events reports add value to the benefit-risk profile
- Identify key topics of ICH guidelines and discuss how the harmonization builds a healthier pharmacovigilance system
- Discuss trends for the future of pharmacovigilance
Speaker(s)
Speaker
Fernanda Simioni, MPharm
ANVISA, Brazil
Specialist Health Surveillance - Pharmacovigilance
Speaker
Janet Hormbrey, DrMed, MRCP, MSc, FFPM
Merck & Co, Inc., United States
AVP Global Pharmacovigilance
Speaker
Melissa Truffa, RPh
Abbvie, United States
Director, Policy and Strategy Evaluation, Pharmacovigilance Excellence
Closing Remarks
Rosana M. Mastellaro, PharmD, RPh
Sindusfarma, Brazil
Director, Technical Regulatory Affairs and Innovation
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