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DIA 2021 Global Annual Meeting
Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA
Nobumasa Nakashima, PhD
- Associate Executive Director for International Programs
- Pharmaceuticals and Medical Devices Agency (PMDA), 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.
Theresa Mullin, PhD
- Associate Director for Strategic Initiatives, CDER
- FDA, United States
Agnès Saint-Raymond, DrMed
- Head of Division International Affairs
- European Medicines Agency, Netherlands
Peter Honig, MD, MPH, FACP
- Senior Vice President Global Regulatory Affairs and Group Head Development China
- Pfizer Inc, United States