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Session 4: Regulatory Cooperation and Reliance Session
Session Chair(s)
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
Director, Evaluation and Control of Biológicals/Research, ANMAT, Argentina
VISION PARA LAS ARNs DE REFERENCIA DE OPS
Raj Long, MED, MSC
Deputy Director, Safety and Pharmacovigilance, Bill and Melinda Gates Foundation, United Kingdom
Smart Safety Surveillance (TripleS)- Pharmacovigilance Strengthening in Low- to Middle-Income Countries (LMIC)
Andrea Best, DO, MPH
Vice President and Head of Patient Safety, Gilead Sciences, United States
Smart Safety Surveillance (TripleS)-Opportunities for industry colloboration on PV efforts in Low to Middle Income Countries
Mike Ward
Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO), Switzerland
WHO-Listed Authorities: What Does it Mean and Why is it Important in Promoting Reliance
Patrick Brady, PHARMD
Global Head, Therapeutic Innovation & Regulatory Science, IQVIA, United States
Regulatory Cooperation and Reliance Session: Industry Perspective
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