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[V6-S6] Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data
Session Chair(s)
Hidetoshi Misawa
Senior Manager, Clinical Data Integration and Operations Group 1
Pfizer Japan Inc., Japan
In October 2016, the PMDA will begin to accept the submission of, and review, electronic study data. Due to differences between PMDA and FDA requirements for the electronically-submitted study data, it will be necessary for some companies to convert past study data into this electronic submission format. This session will sort out what this will change in both industry’s NDA preparation process and the regulator’s review process. We will also determine answers to such questions as: “What study data is most appropriate for NDA?”, “How should applicants prepare the NDA dossier?”, “How will the submitted electronic study data impact business and review timelines?” and “How should companies address these changes?” Panelists representing industry and regulatory perspectives will discuss these emerging issues from the standpoints of regulation and data science.
Speaker(s)
Implementation of Advanced Review with Electronic Study Data in PMDA
Mayumi Shikano, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Center Director (for Advanced Review with Electronic Data Promotion)
Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data
Natsuko Hamada
Swedish Orphan Biovitrum Japan, Japan
Head of Regulatory Affairs
E-Data Submission - Make It Happen
Azusa Tsukida
Senior Advisor, Vivli, Japan
Update on Required Study Data Standards: Technical Rejection of Submissions
Ron Fitzmartin, PhD, MBA
FDA, United States
Senior Advisor, Office of Regulatory Operations, CBER
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