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Session 7 - FDA-PMDA Regulatory Special Session: PMDA-FDA Collaboration on Electronic Data Submission
Session Chair(s)
Yumiko Asami
Chapter Head of Clinical Data Science
Boehringer Ingelheim, Japan
Yukikazu Hayashi
Assistant Head of Clinical Development
A2 Healthcare Corporation, Japan
PMDA published series of guidance on electronic data submissions in April 2015 and many of the technical questions have been clarified. On the other hands, there are many questions how PMDA and FDA collaborate on electronic data submission, acceptance of eNDA, and future data use, etc. This special PMDA-FDA session is organized to hear and understand the status of e-submission to PMDA and FDA, the differences in acceptance of electronic data in PMDA and FDA, and the future data utilization in PMDA and FDA.
Speaker(s)
Special Presentation from PMDA: PMDA Update on Advanced Review with Electronic Data
Yuki Ando, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Senior Scientist for Biostatistics
Special Presentation from FDA: FDA Perspective on the Common Protocol Template
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Informatics Advisor, Office of Regulatory Operations, CBER
Mayumi Shikano, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Center Director (for Advanced Review with Electronic Data Promotion)
Naruhiko Hiramoto
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director for Information System Coordination
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
Steve Wilson, PhD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
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