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DoubleTree by Hilton Grand Biscayne Bay

Feb 21, 2019 7:00 AM - Feb 22, 2019 5:00 PM

1717 N Bayshore Drive, Miami, FL 33132

Latin America Regulatory Conference

Join global regulators, industry, and academia to engage in a series of strategic discussions on current regulatory landscape, globalization, and harmonization initiatives in Latin America.

Session 4: Regulatory Cooperation and Reliance Session

Session Chair(s)

Analia  Porras

Analia Porras

Unit Chief, Medicines and Health Technologies, Pan American Health Organization (PAHO), United States

This session will look at the growing trend of regulatory cooperation and reliance amongst regulatory authorities across the Americas and globally. Developing and improving regulatory systems requires highly-skilled human resources and large public investments among others. In addition, the globalization of the medical products markets has pushed regulatory systems to act internationally in order to ensure the safety, quality, and effectiveness of the products that are consumed locally. Reliance and cooperation can enhance regulatory performance, support both budding and mature regulatory systems and, ultimately, speed access to medical products.

Speaker(s)

Patricia  Aprea, MD

VISION PARA LAS ARNs DE REFERENCIA DE OPS

Director, Evaluation and Control of Biológicals/Research, ANMAT, Argentina

Raj  Long, MED, MSC

Smart Safety Surveillance (TripleS)- Pharmacovigilance Strengthening in Low- to Middle-Income Countries (LMIC)

Deputy Director, Safety and Pharmacovigilance, Bill and Melinda Gates Foundation, United Kingdom

Andrea  Best, DO, MPH

Smart Safety Surveillance (TripleS)-Opportunities for industry colloboration on PV efforts in Low to Middle Income Countries

Vice President and Head of Patient Safety, Gilead Sciences, United States

Mike  Ward

WHO-Listed Authorities: What Does it Mean and Why is it Important in Promoting Reliance

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO), Switzerland

Patrick  Brady, PHARMD

Regulatory Cooperation and Reliance Session: Industry Perspective

Global Head, Therapeutic Innovation & Regulatory Science, IQVIA, United States

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