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Global Development Using Expedited Pathways in Established and Emerging Markets
Session Chair(s)
Maria Cristina Mota Pina, MBA
Head of Intercontinental Regulatory Policy & Intelligence, AbbVie, 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)
Jarbas Barbosa da Silva, MD, PHD
Assistant Director, Pan American Health Organization, United States
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Alberto Grignolo, PHD
Editor-in-Chief, DIA Global Forum, United States
Denise Bonamici, MSC
Head of Regulatory Science and Policy - LATAM, Sanofi, Brazil
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