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Session 1: Regional and Global Regulatory Priority Updates
Session Chair(s)
Juliana Perlow
Director, Regulatory Affairs-CMC, GRACS CMC – Latin America
MSD, Brazil
Fernanda Lessa, MBA, MPH
Health Regulatory Systems
Consultant, Switzerland
This session is intended for each National Regulatory Authority (NRA) to provide a summary of the progress made on their regulatory projects as well as their priorities for 2020. Each NRA will have approximately 10-15 minutes to provide an update on progress made on several local, regional, and global projects as well as their priorities for the year that affect regulators and manufacturers/regulated sector in Latin America. A Q&A panel discussion will be held at the end of this session to provide any clarification where necessary.
Learning Objective :
Upon completion of this session, the participant should be able to:
- Understand the progress made by NRAs in their projects
- Identify NRAs priorities for 2020
- Understand the impact of projects and priorities for regulators and manufacturers
Speaker(s)
Speaker
Patricia Aprea, MD
ANMAT, Argentina
Director, Evaluation and Control of Biológicals/Research
Speaker
Renata De Lima Soares
Anvisa, Brazil
Regulation and Health Surveillance Specialist
Speaker
Dayana Priscila Donoso Paz, Eng.
National Agency for Regulation, Control and Health Surveillance, Ecuador
Speaker
Nicole Ennis, MSc
Caribbean Public Health Agency, Jamaica
Head Medicines Quality Control and Surveillance Department
Speaker
Mario Melendez
Director Nacional, El Salvador
Director Nacional de Medicamentos
Speaker
Charles Preston, MD, MPH, FACPM
Pan American Health Organization (PAHO), United States
Advisor, Regulatory System Strengthening for Medicines & Other Health Technology
Speaker
Mabel Romero
INVIMA, Colombia
Directorate of Medical Devices and Other Technologies
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