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Convergence of the Regulatory Pathways for Advanced Therapy Medicinal Products
Session Chair(s)
Peter W. Marks, MD, PhD
Director, Center for Biologics Evaluation and Research
FDA, United States
Advanced Therapy Medicinal Products (ATMPs) include gene therapy, somatic-cell therapy, and tissue-engineered products. Collectively, these products are being developed in an evolving landscape and are associated with unique developmental challenges because of distinct manufacturing, clinical trial, and regulatory requirements. A 75-minute session is proposed facilitating the presentation and discussion of perspectives from several experienced regulatory agencies. An objective would be to provide a global overview of the various frameworks in place for the development of ATMPs, making note of ongoing and planned harmonization and cooperation projects.
This session will include collective short talks by CBER (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, and possibly a representative from Alliance for Regenerative Medicine (ARM) on the nature and importance of regulatory convergence with ATMPs. This would be followed by a interactive session with the speaker panel and the audience.
Learning Objective : Describe the regulatory pathway for advanced therapy medicinal products in various global regions.
Speaker(s)
EMA Update
Tony Humphreys, MPharm
European Medicines Agency, Netherlands
Head of the Regulatory Science and Innovation Task Force
PMDA Update
Nobumasa Nakashima
Cabinet Office, Japan
Health Policy Director, National Healthcare Policy Secretariat
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