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Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA
Session Chair(s)
Nobumasa Nakashima
Professor, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan
Early access programs are implemented in EU, Japan, US and many other countries/regions, and many products are approved by utilizing these programs. In this session, speakers share and review the programs and discuss its future direction.
Learning Objective : Outline early access programs provided by each regulatory agency; Discuss the achievements of the early access programs offered by each regulatory agency; Identify how to foster a dialogue among stakeholders on what is expected for the early access programs to further address regulatory needs.
Speaker(s)
Theresa Mullin, PHD
Associate Center Director - CDER, FDA, United States
FDA Update
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
EMA Update
Peter Honig, MD, MPH, FACP
, Advisor and Board Member, United States
Industry Update
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