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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)
FDA Update
Theresa Mullin, PHD
FDA, United States
Associate Center Director - CDER
EMA Update
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Industry Update
Peter Honig, MD, MPH, FACP
Advisor and Board Member, United States