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A Global Update on Orphan Drugs
Session Chair(s)
Noriaki Murao, DIAFellow, MS
Senior Consultant (Pharmaceuticals)
NM Consulting, Japan
This symposium addresses the current status and forthcoming activities related to orphan drugs in North America, EU and Japan. Orphan drug development is considered essential in these regions, and the various provisions to accelerate the development of orphan drugs have been implemented. However, some challenges still remain for the companies and the agencies wishing to pursue development and approval of orphan drugs in these regions.
Learning Objective : Discuss an overview of the regulation and development of orphan drugs in North America, EU and Japan; Describe the new regulatory environment changes.
Speaker(s)
Building on the Success of 15 Years of European Orphan Drug Legislation
Kristina Larsson, MS
European Medicines Agency, Netherlands
Head of Orphan Medicines, Division for Human Medicines Evidence Generation
Mastering Regulatory Approvals in New Orphan Drug Markets
Lewis Lau, RAC
Humber-RAC Group, Canada
Researcher
Global Development and Approval by Cooperation of Key Regulatory Agencies
Junko Sato, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director