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DIA 2021 Global Annual Meeting


Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA

Session Chair(s)

Nobumasa  Nakashima, PhD

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.

Speaker(s)

Theresa  Mullin, PhD

FDA Update

Theresa Mullin, PhD

  • Associate Director for Strategic Initiatives, CDER
  • FDA, United States
Agnès  Saint-Raymond, DrMed

EMA Update

Agnès Saint-Raymond, DrMed

  • Head of Division International Affairs
  • European Medicines Agency, Netherlands
Peter  Honig, MD, MPH, FACP

Industry Update

Peter Honig, MD, MPH, FACP

  • Senior Vice President Global Regulatory Affairs and Group Head Development China
  • Pfizer Inc, United States