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Tokyo Big Sight

Nov 13, 2016 9:30 AM - Nov 15, 2016 5:30 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

13th DIA Japan Annual Meeting 2016

[V6-S6] Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data

Session Chair(s)

Hidetoshi  Misawa

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)

Mayumi  Shikano, PhD

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)

Natsuko  Hamada

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

Azusa  Tsukida

E-Data Submission - Make It Happen

Azusa Tsukida

Senior Advisor, Vivli, Japan

Ron  Fitzmartin, PhD, MBA

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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