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Global Development Using Expedited Pathways in Established and Emerging Markets
Session Chair(s)
Maria Cristina Mota Pina, MBA
Director, Regulatory Policy and Intelligence -Japan, Emerging Markets, Australia
Latin America Federation of Pharmaceutical Industry (FIFARMA), United States
FFDA, EMA, and PMDA have well-established pathways for approval of innovative products that are for unmet medical needs. Some emerging markets are establishing such pathways as well. This session will discuss how governments accelerate the access of such type of products in the emerging markets as well as in established markets. What are the challenges and opportunities that regulators and industry face around the world when filing for expedited approval of a product that is for high unmet need, where access is a priority for patients?
Learning Objective : Identify how expedited pathways work in established markets and how emerging markets are developing new pathways to expedite approval of products for high unmet medical need; Describe how regulators and industry shared their experiences with these pathways and market prioritization; Compare the differences when the review is independent or when using pathways such as mutual reliance and mutual recognition.
Speaker(s)
ANVISA Perspective
Jarbas Barbosa da Silva, MD, PhD
Pan American Health Organization, United States
Assistant Director
Facilitated Regulatory Pathways in Maturing Agenices: The Benefits of Reliance and Alignment
Lawrence Liberti, PhD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for for Regulatory Science
Update on the Status of Expedited Pathways in the Mature Markets
Alberto Grignolo, PhD
DIA, United States
Editor-in-Chief, DIA Global Forum
EFPIA Position Paper: White Paper on Reliance and Expedited Pathways in Emerging Markets
Denise Bonamici, MSc
Sanofi, Brazil
Head of Regulatory Science and Policy - LATAM
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