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Tokyo Big Sight

Nov 16, 2014 9:00 AM - Nov 18, 2014 6:30 PM

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

11th Annual Meeting DIA Japan 2014

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[V1-S4] Virtual Meeting of PMDA’s Scientific Consultation: Points to Maximize an Efficiency of the Meeting

Session Chair(s)

Yoshiaki Uyama, PhD, MS, RPh

Yoshiaki Uyama, PhD, MS, RPh

Associate Executive Director

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

It is critical for both applicant and regulator to have a proper understanding of the objectives of a consultation, including the background or fundamental problems faced in order to make a productive discussion in the scientific consultation or NDA review process possible. In reality, however, the usefulness or comprehension varies depending on how the issues are addressed or how the opinions are written in the briefing or response materials. This session will focus on PMDA scientific consultation. In this session, the panelists will replicate typical consultation by using virtual new product. This will provide some ideas on how to avoid miscommunication and how to maximize the value of consultation. The panelists acting as applicants will replicate the process how they decide their response policy to the inquiry from PMDA and how they find a compromise. Conversely, panelists acting as PMDA will disclose the heated internal discussion that isn’t open to the public. Just as in last year’s session, the session will use a voting system. Other topics of discussion include CMC, nonclinical study, and phase III study including multiregional clinical trial, among others.

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